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Trial record 11 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Temozolomide Alone or With Pegylated Interferon-Alpha 2b (PGI) in Melanoma Patients

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ClinicalTrials.gov Identifier: NCT00525031
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: Temozolomide (TMZ)
Drug: Pegylated Interferon Alpha-2b (PGI)
Enrollment 55
Recruitment Details Recruitment Period: August 31, 2006 to May 10, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details Three participants of 55 enrolled were excluded due to ineligibility prior to assignment to groups.
Arm/Group Title Temozolomide (TMZ) Temozolomide (TMZ) + Pegylated Interferon-alpha 2b (PGI)
Hide Arm/Group Description TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
Period Title: Overall Study
Started 27 25
Completed 26 24
Not Completed 1 1
Reason Not Completed
Disease Progression             1             1
Arm/Group Title TMZ Alone TMZ + PGI Total
Hide Arm/Group Description TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 27 25 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 25 participants 52 participants
58
(31 to 71)
62
(32 to 82)
60
(31 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
Female
14
  51.9%
9
  36.0%
23
  44.2%
Male
13
  48.1%
16
  64.0%
29
  55.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 27 participants 25 participants 52 participants
27
 100.0%
25
 100.0%
52
 100.0%
1.Primary Outcome
Title Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD)
Hide Description Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
Time Frame Evaluated after a total of 8 weeks of therapy before definitive surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TMZ Alone TMZ + PGI
Hide Arm/Group Description:
TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks.
TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
CR, PR, SD
4
  22.2%
7
  38.9%
PD
14
  77.8%
11
  61.1%
2.Primary Outcome
Title Response to Neoadjuvant Therapy: Overall Clinical Responses
Hide Description Response to neoadjuvant therapy reported as number of participants with clinical response, defined as Clinical Complete Response (CR): Disappearance of all clinical evidence of visible tumor. Partial Response (PR) : 30% or > decrease in the sum of the of the longest diameter of target lesions, taking as reference the baseline sum longest diameter persisting for at least 4 weeks. Progressive Disease (PD): > 20% increase in sum of longest diameter of target lesions, reference baseline sum longest diameter. Appearance new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
Time Frame Evaluated after a total of 8 weeks of therapy before definitive surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall Study
Hide Arm/Group Description:
Arm A: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. Arm B: TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
Overall Number of Participants Analyzed 50
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   2.0%
Partial Response
15
  30.0%
Stable Disease
3
   6.0%
Progressive Disease
31
  62.0%
Time Frame Adverse event data were collected from first cycle (8 weeks) of neoadjuvant therapy before undergoing surgical resection and up to 3 additional cycles (24 weeks) following definitive surgery as adjuvant therapy for total of 32 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TMZ Alone TMZ + PGI
Hide Arm/Group Description TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) for a total of 8 weeks. TMZ 150 mg/m^2 oral once daily for 7 days, followed by 7 days off (alternating weekly) and PGI 0.5 mcg/kg subcutaneous injection once weekly for a total of 8 weeks.
All-Cause Mortality
TMZ Alone TMZ + PGI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TMZ Alone TMZ + PGI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      8/25 (32.00%)    
Blood and lymphatic system disorders     
LEUKOCYTES INCREASED/Leukocytosis  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Investigations     
NEUTROPHILS INCREASED (ANC/AGC)  1  0/27 (0.00%)  0 1/25 (4.00%)  1
LYMPHOPENIA  1  0/27 (0.00%)  0 3/25 (12.00%)  3
PLATELETS DECREASED  1  0/27 (0.00%)  0 3/25 (12.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
TMZ Alone TMZ + PGI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/27 (96.30%)      24/25 (96.00%)    
Blood and lymphatic system disorders     
LEUKOCYTES INCREASED/Leukocytosis  1  2/27 (7.41%)  2 7/25 (28.00%)  7
Gastrointestinal disorders     
CONSTIPATION  1  11/27 (40.74%)  11 14/25 (56.00%)  14
DIARRHEA  1  0/27 (0.00%)  0 5/25 (20.00%)  5
INDIGESTION  1  1/27 (3.70%)  1 0/25 (0.00%)  0
VOMITING  1  4/27 (14.81%)  4 6/25 (24.00%)  6
General disorders     
FATIGUE  1  12/27 (44.44%)  12 17/25 (68.00%)  17
FEVER WITHOUT NEUTROPENIA  1  0/27 (0.00%)  0 3/25 (12.00%)  3
FLU-LIKE SYNDROME  1  1/27 (3.70%)  1 7/25 (28.00%)  7
HEARTBURN  1  0/27 (0.00%)  0 2/25 (8.00%)  2
NAUSEA  1  11/27 (40.74%)  11 16/25 (64.00%)  16
RIGORS/CHILLS  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Injury, poisoning and procedural complications     
INJECTION SITE REACTION  1  1/27 (3.70%)  1 14/25 (56.00%)  14
Investigations     
ALANINE TRANSAMINASE (ALT) INCREASED  1  0/27 (0.00%)  0 6/25 (24.00%)  6
ASPARTATE AMINOTRANSFERASE (AST) INCREASED  1  0/27 (0.00%)  0 6/25 (24.00%)  6
ELEVEVATED Serum Glutamic-Oxaloacetic Transaminase (SGOT)  1  0/27 (0.00%)  0 1/25 (4.00%)  1
HEMOGLOBIN INCREASED  1  3/27 (11.11%)  3 4/25 (16.00%)  4
LEUKOPENIA  1  2/27 (7.41%)  2 5/25 (20.00%)  5
LYMPHOCYTE COUNT DECREASED  1  0/27 (0.00%)  0 1/25 (4.00%)  1
LYMPHOPENIA  1  5/27 (18.52%)  5 7/25 (28.00%)  7
NEUTROPHILS DECREASED (Absolute neutrophil count/ANC)  1  2/27 (7.41%)  2 7/25 (28.00%)  7
PLATELETS DECREASED  1  5/27 (18.52%)  5 10/25 (40.00%)  10
WHITE BLOOD CELL DECREASED  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Metabolism and nutrition disorders     
ANOREXIA  1  10/27 (37.04%)  10 9/25 (36.00%)  9
HYPERGLYCEMIA  1  0/27 (0.00%)  0 2/25 (8.00%)  2
HYPOCALCEMIA  1  0/27 (0.00%)  0 1/25 (4.00%)  1
HYPOMAGNESEMIA  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders     
PAIN (EXTREMITY-LIMBS)  1  2/27 (7.41%)  2 1/25 (4.00%)  1
PAIN (MUSCLE)  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders     
DIZZINESS  1  1/27 (3.70%)  1 0/25 (0.00%)  0
PAIN (HEAD/HEADACHE)  1  8/27 (29.63%)  8 16/25 (64.00%)  16
TASTE ALTERATION  1  1/27 (3.70%)  1 3/25 (12.00%)  3
Psychiatric disorders     
MOOD ALTERATION  1  0/27 (0.00%)  0 3/25 (12.00%)  3
Renal and urinary disorders     
CYSTITIS  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders     
ALOPECIA  1  1/27 (3.70%)  1 2/25 (8.00%)  2
PAIN (SKIN)  1  0/27 (0.00%)  0 1/25 (4.00%)  1
PRURITUS  1  1/27 (3.70%)  1 3/25 (12.00%)  3
PRURITUS/ITCHING  1  1/27 (3.70%)  1 4/25 (16.00%)  4
RASH/DESQUAMATION  1  0/27 (0.00%)  0 3/25 (12.00%)  3
SWEATING  1  0/27 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Wen-Jen Hwu, MD/Professor, Melanoma Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525031     History of Changes
Other Study ID Numbers: 2005-0143
NCI-2010-00855 ( Registry Identifier: NCI CTRP )
First Submitted: August 31, 2007
First Posted: September 5, 2007
Results First Submitted: June 29, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017