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Trial record 38 of 42 for:    Malignant Hyperthermia 5

Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00539591
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : February 27, 2014
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Melanoma
Interventions Drug: Peginterferon alfa-2b
Drug: Temozolomide
Drug: Recombinant interferon alfa-2b
Enrollment 29
Recruitment Details A total of 29 patients were enrolled between May 9, 2008 and August 22, 2012. Of the 29 participants, 21 were enrolled at St. Jude Children's Research Hospital (SJCRH), 7 at MD Anderson, and 1 at Rady Children's Hospital. Twenty-three participants met stratum A eligibility, 2 met stratum B1 eligibility and 4 met stratum B2 eligibility.
Pre-assignment Details  
Arm/Group Title Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
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Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.

Period Title: Overall Study
Started 23 2 4
Completed 18 0 1
Not Completed 5 2 3
Reason Not Completed
Toxicity             3             0             0
Disease progression             2             2             3
Arm/Group Title Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease Total
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Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.

Total of all reporting groups
Overall Number of Baseline Participants 23 2 4 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 2 participants 4 participants 29 participants
10.3
(2.4 to 20.0)
11.9
(3.96 to 19.89)
18.4
(3.6 to 22.1)
10.77
(2.4 to 22.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 2 participants 4 participants 29 participants
Female
15
  65.2%
0
   0.0%
1
  25.0%
16
  55.2%
Male
8
  34.8%
2
 100.0%
3
  75.0%
13
  44.8%
1.Primary Outcome
Title Tumor Response Rate
Hide Description Tumor response rate of stratum B1 participants was evaluated after 1 treatment course of temozolomide plus peginterferon ɑ-2b. Complete response (CR) and partial response (PR) confirmed with repeated scan at least 4 weeks apart following completion of course 1 therapy. CR defined as disappearance of all target and non-target lesions with no new lesions detected. If available, no disease must be detected by immunocytology or serum tumor markers. PR defined as at least 30% decrease in disease measurement compared to disease measurement at study entry with no new lesions detected. Progressive disease (PD) defined as at least 20% increase in the disease measurement compared to the smallest disease measurement recorded since start of treatment, or appearance of one or more new lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD compared to smallest disease measurement since start of treatment.
Time Frame 8 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stratum B1
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Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease

Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Interventions: Temozolomide, peginterferon ɑ-2b

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Progressive Disease 2
Clinical Remission 0
2.Primary Outcome
Title Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2
Hide Description

The objective was to assess the safety of temozolomide administered in combination with peginterferon a-2b in Stratum B participants.

Accrual was suspended any time during therapy if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:

  • Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
  • Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
  • Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
  • Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
  • Grade 4 mood alteration (suicidal ideation; danger to self or others)
Time Frame 52 weeks
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Hide Analysis Population Description
This toxicity report was based on intention to treat population (ITT), all patients enrolled were included. The study did not meet its accrual goals within the planned timeframe due to slow accrual.
Arm/Group Title Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
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Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.

Overall Number of Participants Analyzed 2 4
Measure Type: Number
Unit of Measure: participants
0 0
3.Primary Outcome
Title Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients
Hide Description

The objective was to study the feasibility and safety of administering peginterferon a-2b weekly for 48 weeks following the initial induction phase to Stratum A participants.

Accrual was suspended during the 48-week course if 2 or more of 6, 4 or more of 12, 6 or more of 18, 8 or more of 24, 10 or more of 30 participants experienced target toxicity defined as:

  • Grade 4 non-hematologic (non-hem) toxicity that does not resolve to ≤grade 1 within 2 weeks from the time next dose is due and is determined to be probably or definitely related to protocol therapy
  • Grade 4 non-hem toxicity that is NOT constitutional symptoms (fever, chills, fatigue and/or pain)
  • Grade 3 elevations in creatinine or BUN that are determined to be probably or definitely related to protocol therapy
  • Grade 4 cardiopulmonary toxicity that is determined to be probably or definitely related to protocol therapy
  • Grade 4 mood alteration (suicidal ideation; danger to self or others)
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants for the analysis was based on the intent to treat population, all patients enrolled were included. Participants were enrolled on Stratum A until the accrual goals were met on Stratum B.
Arm/Group Title Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b
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Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
Grade 4 non-hem toxicity 2
Grade 4 non-hem/NOT constitutional 0
Grade 3 elevations in creatinine or BUN 0
Grade 4 cardiopulmonary toxicity 0
Grade 4 mood alteration 1
4.Primary Outcome
Title Probability of Event-free Survival (EFS) of Stratum A Participants
Hide Description The probability of EFS was estimated as time to first event (relapse, death or second malignancy). As of April 2016, 21 out of 23 participants had no events. The EFS rate was estimated by Kaplan-Meier method.
Time Frame 3 years from diagnosis
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b
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Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability
0.913
(0.79 to 1.00)
5.Other Pre-specified Outcome
Title Median Steady State Trough Concentration of Pegylated Interferon ɑ-2B
Hide Description

The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed.

Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.

Time Frame Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient had evaluable data in Stratum B and is not included in the final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: pcg/ml
52.8
(13.8 to 152.4)
6.Other Pre-specified Outcome
Title Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B
Hide Description

Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.

Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 through infinity.

Time Frame Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.
Arm/Group Title Week 5 - First Dose Week 28 - Steady State
Hide Arm/Group Description:
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
Overall Number of Participants Analyzed 7 6
Median (Full Range)
Unit of Measure: pcg * hr/ml
50556
(36166 to 58980)
48480
(34024 to 59857)
7.Other Pre-specified Outcome
Title ɑ Half Life of Pegylated Interferon ɑ-2B
Hide Description

Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.

Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.

Time Frame Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: hours
24.8
(16.6 to 40.6)
8.Other Pre-specified Outcome
Title Volume of Central Compartment (Vc) of Pegylated Interferon ɑ-2B
Hide Description

Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.

Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.

Time Frame Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only one Stratum B patient had evaluable data and is not included in final analysis, because data from more than one patient are required for nonlinear-mixed effects modeling due to differences in clinical variables. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: ml/kg
772
(594 to 1410)
9.Other Pre-specified Outcome
Title Apparent Clearance (CL) of Pegylated Interferon ɑ-2B
Hide Description

Pharmacokinetic (PK) analysis of pegylated ɑ-2b included only Stratum A patients who had PK studies performed.

Samples were analyzed for pegylated interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.

Time Frame Before first dose, and 24, 96 and 168 hours after dose during weeks 5 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only one Stratum B patient had evaluable data and is not included in final analysis due to differences in clinical variables, because data from more than one patient are required for nonlinear-mixed effects modeling. Two patients in Week 5 and three in Week 28 were excluded due to inadequate sampling to characterize an AUC value.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: ml/hr/kg
19.8
(16.7 to 31.4)
10.Other Pre-specified Outcome
Title Area Under the Curve (AUC) of Interferon ɑ-2b
Hide Description Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM. AUC is given as Time 0 to infinity.
Time Frame Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic(PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: pcg * hr/ml
5026
(2642 to 10270)
11.Other Pre-specified Outcome
Title Half-Life of Interferon ɑ-2b
Hide Description Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.
Time Frame Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.
Arm/Group Title Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b
Hide Arm/Group Description:
Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: hours
ɑ half-life
0.7
(0.4 to 1.4)
ß half-life
14.7
(12.5 to 28.2)
12.Other Pre-specified Outcome
Title Volume of Central Compartment (Vc) of Interferon ɑ-2b
Hide Description Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.
Time Frame Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.
Arm/Group Title Interferon ɑ-2b
Hide Arm/Group Description:
Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: l/m^2
25.1
(13.9 to 49.2)
13.Other Pre-specified Outcome
Title Systemic Clearance (CL) of Interferon ɑ-2B
Hide Description Samples were analyzed for interferon ɑ-2b concentrations by using the VeriKine Human Interferon Alpha ELISA Kit following the manufacturer's instructions, and concentration-time data were analyzed by nonlinear-mixed effects modeling as implemented in NONMEM.
Time Frame Before first dose, and 1, 2, 4, 6, 8, 12, and 24 hours postinfusion
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis of pegylated ɑ-2b included only patients within Stratum A who had PK studies performed. Only one patient had evaluable data in Stratum B and is not included in the final analysis due to differences in clinical variables.
Arm/Group Title Interferon ɑ-2b
Hide Arm/Group Description:
Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: l/hr/m^2
15.3
(7.5 to 29.1)
14.Other Pre-specified Outcome
Title Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum A)
Hide Description QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.
Time Frame Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
This QOL analysis included patients only within Stratum A.
Arm/Group Title Pretherapy Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed before start of therapy.
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 15 15 17 14 14 17 15 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
75.5  (18.4) 71.6  (18.7) 77.2  (16.3) 79.3  (17.4) 77.8  (20.6) 80.6  (15.6) 80.4  (16.1) 87.5  (12.5) 91.0  (7.1)
15.Other Pre-specified Outcome
Title Mean Total PedsQL 4.0 Scores for Child Quality of Life (QoL) Assessments (Stratum B)
Hide Description QoL assessments were completed using Pediatrics Quality of Life Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for child report = 83.0 ± 14.8.
Time Frame Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.
Arm/Group Title Pretherapy Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed before start of therapy.
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 1 1 1 1 1 0 1 0 0
Measure Type: Number
Unit of Measure: units on a scale
90.3 93.1 72.8 79.2 68.1 65.6
16.Other Pre-specified Outcome
Title Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum A)
Hide Description QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.
Time Frame Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
This QOL analysis included patients only within Stratum A.
Arm/Group Title Pretherapy Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed before start of therapy.
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 16 15 17 13 16 17 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
70.3  (19.1) 71.8  (16.4) 74.4  (17.9) 79.1  (16.6) 79.0  (19.0) 82.2  (14.5) 87.5  (15.3) 86.0  (17.6) 87.3  (17.5)
17.Other Pre-specified Outcome
Title Mean Total PedsQL 4.0 Scores for Parent Quality of Life Assessments (Stratum B)
Hide Description QoL assessments were completed using Pediatrics Quality of Live Inventory (PedsQL v4.0). Scale range is 0-100 with higher scores reflecting better quality of life. PedsQL 4.0 healthy sample normative mean ± SD for parent report = 87.6 ± 12.3.
Time Frame Pretherapy; Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.
Arm/Group Title Pretherapy Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed before start of therapy.
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 1 1 1 0 0 0 0 0 0
Measure Type: Number
Unit of Measure: units on a scale
77.6 72.2 89.1
18.Other Pre-specified Outcome
Title Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum A)
Hide Description QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.
Time Frame Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.
Arm/Group Title Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 17 19 17 17 16 17 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
71.1  (17.2) 76.1  (15.4) 79.2  (19.2) 78.5  (14.7) 77.1  (16.0) 77.0  (16.5) 83.7  (18.0) 85.4  (8.9)
19.Other Pre-specified Outcome
Title Mean Total PedsQL 3.0 Scores for Child Cancer Quality of Life (QoL) Assessments (Stratum B)
Hide Description QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.
Time Frame Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected at Week 24, and the patient was taken off study prior to 6 months after end of therapy.
Arm/Group Title Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 1 1 1 1 0 1 0 0
Measure Type: Number
Unit of Measure: units on a scale
92.8 90.1 93.2 79.6 67.4
20.Other Pre-specified Outcome
Title Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum A)
Hide Description QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.
Time Frame Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
PedsQL v3.0 was not completed pretherapy. This QOL analysis included patients only within Stratum A.
Arm/Group Title Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 19 19 17 18 16 16 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.2  (13.9) 75.1  (15.2) 81.4  (11.6) 78.7  (17.7) 81.6  (17.1) 85.6  (13.8) 85.0  (11.5) 89.1  (11.6)
21.Other Pre-specified Outcome
Title Mean Total PedsQL 3.0 Scores for Parent Cancer Quality of Life (QoL) Assessments (Stratum B)
Hide Description QoL assessments were completed using Pediatrics Cancer Quality of Life Inventory (PedsQL v3.0). Scale range is 0-100 with higher scores reflecting better quality of life.
Time Frame Weeks 2, 4, 8, 12, and 24; and End of therapy at 6 months and 12 months post
Hide Outcome Measure Data
Hide Analysis Population Description
PedsQL v3.0 was not completed pretherapy. Only one patient had evaluable data in Stratum B. The raw score, rather than the mean +/- SD, is presented. Data was not collected after Week 4.
Arm/Group Title Week 2 Week 4 Week 8 Week 12 Week 24 End of Therapy 6 Months After End of Therapy 12 Months After End of Therapy
Hide Arm/Group Description:
QoL assessment completed at Week 2.
QoL assessment completed at Week 4.
QoL assessment completed at Week 8.
QoL assessment completed at Week 12.
QoL assessment completed at Week 24.
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
QoL assessment completed 12 months after end of therapy.
Overall Number of Participants Analyzed 1 1 0 0 0 0 0 0
Measure Type: Number
Unit of Measure: units on a scale
67.7 71.4
22.Other Pre-specified Outcome
Title BASC-2 Psychological Assessment (Stratum A)
Hide Description The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.
Time Frame Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This QOL analysis included patients only within Stratum A.
Arm/Group Title Pretherapy Week 4 Week 24 End of Therapy 6 Months After End of Therapy
Hide Arm/Group Description:
Psychological assessment completed before start of therapy.
Psychological assessment completed at Week 4
Psychological assessment completed at Week 24
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
Overall Number of Participants Analyzed 21 21 19 18 16
Mean (Standard Deviation)
Unit of Measure: T score
44.9  (8.1) 45.9  (8.3) 44.2  (6.9) 47.2  (11.1) 42.3  (7.2)
23.Other Pre-specified Outcome
Title BASC-2 Psychological Assessment (Stratum B)
Hide Description The Behavioral Assessment System for Children, 2nd Edition (BASC-2) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The behavior system index (BSI) T-score (range 0-100) is reported for the BASC-2 assessment. Higher scores reflect greater behavioral problems.
Time Frame Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.
Arm/Group Title Pretherapy Week 4 Week 24 End of Therapy 6 Months After End of Therapy
Hide Arm/Group Description:
Psychological assessment completed before start of therapy.
Psychological assessment completed at Week 4
Psychological assessment completed at Week 24
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Other Pre-specified Outcome
Title BRIEF Psychological Assessment (Stratum A)
Hide Description The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.
Time Frame Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This QOL analysis included patients only within Stratum A.
Arm/Group Title Pretherapy Week 4 Week 24 End of Therapy 6 Months After End of Therapy
Hide Arm/Group Description:
Psychological assessment completed before start of therapy.
Psychological assessment completed at Week 4
Psychological assessment completed at Week 24
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
Overall Number of Participants Analyzed 17 17 13 14 11
Mean (Standard Deviation)
Unit of Measure: T score
47.9  (12.8) 50.8  (11.9) 48.6  (12.4) 47.6  (12.6) 42.6  (8.1)
25.Other Pre-specified Outcome
Title BRIEF Psychological Assessment (Stratum B)
Hide Description The Behavioral Rating Inventory of Executive Function (BRIEF) was administered to parents, assessing for any effects on behavior or mood in children undergoing study therapy. The global executive composite (GEC) T-score (range 0-100) is reported for the BRIEF assessment. Higher scores reflect poorer executive function.
Time Frame Pretherapy, Week 4, Week 24, End of Therapy, and 6 Months Post End of Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient had evaluable data in Stratum B, but scores were not available for this instrument due to the age of the patient.
Arm/Group Title Pretherapy Week 4 Week 24 End of Therapy 6 Months After End of Therapy
Hide Arm/Group Description:
Psychological assessment completed before start of therapy.
Psychological assessment completed at Week 4
Psychological assessment completed at Week 24
QoL assessment completed at end of therapy.
QoL assessment completed 6 months after end of therapy.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events are reported from the start of treatment for the first patient in May 2008 through April 2016.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
Hide Arm/Group Description

Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB

Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks.

Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.

Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease

Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined.

All-Cause Mortality
Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/23 (13.04%)      0/2 (0.00%)      0/4 (0.00%)    
Musculoskeletal and connective tissue disorders       
Joint effusion * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Joint function * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders       
Confusion * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Extrapyramidal/involuntary movement/restlessness * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Mood alteration, agitation * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Psychosis (hallucinations/delusions) * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
Seizure * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC version 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b Temozolomide/Peginterferon ɑ-2b With Measureable Disease Temozolomide/Peginterferon ɑ-2b Without Measureable Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/23 (100.00%)      2/2 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders       
Hemoglobin * 1  13/23 (56.52%)  29 2/2 (100.00%)  2 2/4 (50.00%)  11
Leukocytes) total WBC) * 1  22/23 (95.65%)  116 2/2 (100.00%)  4 4/4 (100.00%)  16
Neutrophils/granulocytes (ANC/AGC) * 1  23/23 (100.00%)  142 0/2 (0.00%)  0 4/4 (100.00%)  16
Platelets * 1  15/23 (65.22%)  28 0/2 (0.00%)  0 3/4 (75.00%)  18
Edema: head and neck * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1
Edema: limb * 1  2/23 (8.70%)  5 0/2 (0.00%)  0 1/4 (25.00%)  1
Edema: trunk/genital * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Lymphatics - other * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  2
Cardiac disorders       
Supraventricular and nodal arrhythmia, sinus bradycardia * 1  8/23 (34.78%)  20 0/2 (0.00%)  0 1/4 (25.00%)  3
Supraventricular and nodal arrhythmia, sinus tachycardia * 1  9/23 (39.13%)  22 2/2 (100.00%)  4 1/4 (25.00%)  3
Hypertension * 1  6/23 (26.09%)  21 0/2 (0.00%)  0 2/4 (50.00%)  2
Endocrine disorders       
Hot flashes/flushes * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Thyroid function, low (hypothyroidism) * 1  3/23 (13.04%)  5 0/2 (0.00%)  0 0/4 (0.00%)  0
Eye disorders       
Ocular surface disease * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Ocular/visual - other * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Vision-blurred vision * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders       
Anorexia * 1  18/23 (78.26%)  42 2/2 (100.00%)  2 2/4 (50.00%)  3
Constipation * 1  9/23 (39.13%)  18 0/2 (0.00%)  0 0/4 (0.00%)  0
Dehydration * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Diarrhea * 1  13/23 (56.52%)  32 1/2 (50.00%)  1 4/4 (100.00%)  9
Flatulence * 1  1/23 (4.35%)  1 1/2 (50.00%)  1 0/4 (0.00%)  0
Heartburn/dyspepsia * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 1/4 (25.00%)  1
Mucositis/stomatitis (clinical exam), oral cavity * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Nausea * 1  17/23 (73.91%)  38 0/2 (0.00%)  0 4/4 (100.00%)  9
Taste alteration (dysgeusia) * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Vomiting * 1  12/23 (52.17%)  30 0/2 (0.00%)  0 3/4 (75.00%)  17
General disorders       
Fatigue (asthenia, lethargy, malaise) * 1  20/23 (86.96%)  100 0/2 (0.00%)  0 3/4 (75.00%)  4
Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10e9/L) * 1  16/23 (69.57%)  39 1/2 (50.00%)  1 2/4 (50.00%)  3
Rigors/chills * 1  10/23 (43.48%)  19 0/2 (0.00%)  0 0/4 (0.00%)  0
Sweating (diaphoresis) * 1  2/23 (8.70%)  5 0/2 (0.00%)  0 0/4 (0.00%)  0
Weight gain * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Weight loss * 1  4/23 (17.39%)  9 1/2 (50.00%)  2 1/4 (25.00%)  1
Pain, abdomen NOS * 1  8/23 (34.78%)  16 1/2 (50.00%)  2 2/4 (50.00%)  5
Pain, back * 1  3/23 (13.04%)  22 1/2 (50.00%)  1 2/4 (50.00%)  2
Pain, chest wall * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 1/4 (25.00%)  4
Pain, chest/thorax NOS * 1  3/23 (13.04%)  5 0/2 (0.00%)  0 2/4 (50.00%)  3
Pain, dental/teeth/peridontal * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, external ear * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, extremity-limb * 1  12/23 (52.17%)  27 1/2 (50.00%)  1 0/4 (0.00%)  0
Pain, head/headache * 1  18/23 (78.26%)  257 1/2 (50.00%)  2 2/4 (50.00%)  6
Pain, joint * 1  3/23 (13.04%)  4 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, muscle * 1  6/23 (26.09%)  12 0/2 (0.00%)  0 1/4 (25.00%)  1
Pain, neck * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, pain NOS * 1  8/23 (34.78%)  43 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, stomach * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Pain, throat/pharynx/larynx * 1  7/23 (30.43%)  9 0/2 (0.00%)  0 0/4 (0.00%)  0
Immune system disorders       
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 1  11/23 (47.83%)  19 0/2 (0.00%)  0 2/4 (50.00%)  2
Infections and infestations       
Infection with normal ANC or Grade 1 or 2 neutrophils, lip/perioral * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils, middle ear (otitis media) * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils, nerve-peripheral * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils, sinus * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils, upper airway NOS * 1  3/23 (13.04%)  4 0/2 (0.00%)  0 1/4 (25.00%)  1
Infection with unknown ANC, sinus * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pnemonia) * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1
Metabolism and nutrition disorders       
ALT, SGPT (serum gluatmic pyruvic transaminase) * 1  22/23 (95.65%)  90 0/2 (0.00%)  0 2/4 (50.00%)  10
AST, SGOT (serum glutamic oxaloacetic transaminase) * 1  23/23 (100.00%)  73 1/2 (50.00%)  1 1/4 (25.00%)  3
Albumin, serum-low (hypoalbuminemia) * 1  6/23 (26.09%)  6 1/2 (50.00%)  1 1/4 (25.00%)  1
Alkaline phosphatase * 1  4/23 (17.39%)  6 0/2 (0.00%)  0 0/4 (0.00%)  0
Amylase * 1  8/23 (34.78%)  14 0/2 (0.00%)  0 1/4 (25.00%)  4
Calcium, serum-high (hypercalcemia) * 1  0/23 (0.00%)  0 1/2 (50.00%)  2 0/4 (0.00%)  0
Calcium, serum-low (hypocalcemia * 1  3/23 (13.04%)  5 0/2 (0.00%)  0 0/4 (0.00%)  0
Glucose, serum-high (hyperglycemia) * 1  12/23 (52.17%)  23 1/2 (50.00%)  1 2/4 (50.00%)  5
Glucose, serum-low (hypoglycemia) * 1  10/23 (43.48%)  14 0/2 (0.00%)  0 1/4 (25.00%)  3
Lipase * 1  3/23 (13.04%)  4 0/2 (0.00%)  0 2/4 (50.00%)  5
Magnesium, serum-high (hypermagnesemia) * 1  6/23 (26.09%)  9 0/2 (0.00%)  0 0/4 (0.00%)  0
Magnesium, serum-low (hypomagnesemia) * 1  3/23 (13.04%)  8 0/2 (0.00%)  0 0/4 (0.00%)  0
Metabolic/laboratory - other * 1  7/23 (30.43%)  23 0/2 (0.00%)  0 0/4 (0.00%)  0
Potassium, serum-high (hyperkalemia * 1  5/23 (21.74%)  9 0/2 (0.00%)  0 2/4 (50.00%)  8
Potassium, serum-low (hypokalemia) * 1  4/23 (17.39%)  4 0/2 (0.00%)  0 2/4 (50.00%)  2
Proteinuria * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  1
Sodium, serum-high (hypernatremia) * 1  9/23 (39.13%)  17 0/2 (0.00%)  0 2/4 (50.00%)  2
Triglyceride, serum-high (hypertriglyceridemia) * 1  11/23 (47.83%)  17 0/2 (0.00%)  0 1/4 (25.00%)  1
Uric acid, serum-high (hyperuricemia) * 1  7/23 (30.43%)  7 0/2 (0.00%)  0 3/4 (75.00%)  9
Bilirubin (hyperbilirubinemia) * 1  2/23 (8.70%)  6 0/2 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders       
Dizziness * 1  3/23 (13.04%)  5 0/2 (0.00%)  0 0/4 (0.00%)  0
Mood alteration, agitation * 1  9/23 (39.13%)  23 0/2 (0.00%)  0 0/4 (0.00%)  0
Mood alteration, anxiety * 1  3/23 (13.04%)  3 0/2 (0.00%)  0 1/4 (25.00%)  1
Mood alteration, depression * 1  3/23 (13.04%)  4 0/2 (0.00%)  0 0/4 (0.00%)  0
Neuropathy: sensory * 1  5/23 (21.74%)  8 0/2 (0.00%)  0 0/4 (0.00%)  0
Personality/behavioral * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders       
Incontinence, urinary * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  2
Urinary frequency/urgency * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  2
Reproductive system and breast disorders       
Irregular menses (change from baseline) * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchospasm, wheezing * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  6
Cough * 1  6/23 (26.09%)  8 0/2 (0.00%)  0 1/4 (25.00%)  1
Dyspnea (shortness of breath) * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1
Skin and subcutaneous tissue disorders       
Bruising (in absence of Grade 3 or 4 thrombocytopenia) * 1  4/23 (17.39%)  9 0/2 (0.00%)  0 0/4 (0.00%)  0
Dermatology/skin - other * 1  4/23 (17.39%)  7 0/2 (0.00%)  0 0/4 (0.00%)  0
Dry skin * 1  6/23 (26.09%)  6 0/2 (0.00%)  0 0/4 (0.00%)  0
Flushing * 1  3/23 (13.04%)  7 0/2 (0.00%)  0 1/4 (25.00%)  1
Hair loss/alopecia (scalp or body) * 1  7/23 (30.43%)  8 0/2 (0.00%)  0 1/4 (25.00%)  1
Photosensitivity * 1  1/23 (4.35%)  1 0/2 (0.00%)  0 1/4 (25.00%)  1
Pruritus/itching * 1  5/23 (21.74%)  5 1/2 (50.00%)  1 1/4 (25.00%)  1
Rash/desquamation * 1  20/23 (86.96%)  83 1/2 (50.00%)  2 3/4 (75.00%)  5
Urticaria (hives, welts, wheals) * 1  0/23 (0.00%)  0 1/2 (50.00%)  1 0/4 (0.00%)  0
Vascular disorders       
Hemorrhage, GI, lower GI NOS * 1  3/23 (13.04%)  4 0/2 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage, GI, oral cavity * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage, GI, rectum * 1  2/23 (8.70%)  2 0/2 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage, GI, upper GI NOS * 1  0/23 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  2
Hemorrhage, pulmonary/upper respiratory, nose * 1  3/23 (13.04%)  7 0/2 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage/bleeding - other * 1  2/23 (8.70%)  3 0/2 (0.00%)  0 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC version 3
The study closed early due to poor accrual to stratum B1.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alberto Pappo, MD
Organization: St. Jude Children's Research Hospital
Phone: 901-595-2322
EMail: info@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00539591     History of Changes
Other Study ID Numbers: MEL06
NCI-2011-01192 ( Registry Identifier: NCI Clinical Trials Registration Program ID )
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: September 10, 2013
Results First Posted: February 27, 2014
Last Update Posted: March 23, 2017