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Trial record 7 of 881 for:    "Reticulum Cell Sarcoma"

Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00354107
Recruitment Status : Terminated
First Posted : July 20, 2006
Results First Posted : January 1, 2014
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Large Cell Lymphoma
Recurrent Childhood Anaplastic Large Cell Lymphoma
Interventions Biological: monoclonal antibody SGN-30
Drug: therapeutic hydrocortisone
Drug: ifosfamide
Drug: carboplatin
Drug: etoposide
Drug: methotrexate
Drug: cytarabine
Other: pharmacological study
Other: laboratory biomarker analysis
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Period Title: Overall Study
Started 5
Completed 0
Not Completed 5
Reason Not Completed
Adverse Event             2
Physician Decision             2
Withdrawal by Subject             1
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
5
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 5 participants
5655
(3157 to 5786)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  20.0%
White
3
  60.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
United States 4
Jordan 1
1.Primary Outcome
Title Response
Hide Description Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description:

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percent
50
2.Secondary Outcome
Title Pharmacokinetics of Monoclonal Antibody SGN-30 Assessed by Enzyme-linked Immunosorbent Assay (ELISA) Methods
Hide Description [Not Specified]
Time Frame At baseline, at weeks 1, 2, 5, 6, and 11
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected to assess this study aim and will never be reported.
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description:

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title CD30 Concentrations Levels as Assessed by ELISA
Hide Description Summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals. Although the limited sample size precludes formal hypothesis testing, exploratory analysis of the association between soluble CD30 levels and PK parameters and response will be performed.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected to assess this study aim and will never be reported.
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description:

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Development of Human Antichimeric Antibodies by Using ELISA Method
Hide Description Change in level from baseline to week 11 will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
Time Frame Change from baseline to week 11
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected to assess this study aim and will never be reported.
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description:

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Minimal Residual Disease by Using Southern Blotting or by Real-time Polymerase Chain Reaction (PCR)
Hide Description NPM-ALK expression will be summarized using appropriate descriptive statistics and reported with associated exact 95% confidence intervals.
Time Frame At baseline and weeks 5 and 11
Hide Outcome Measure Data
Hide Analysis Population Description
These data were not collected to assess this study aim and will never be collected.
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description:

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Hide Arm/Group Description

Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).

Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.

All-Cause Mortality
Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Gastrointestinal disorders   
Ascites  1/5 (20.00%)  1
Investigations   
Neutrophil count decreased  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1/5 (20.00%)  1
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders - Other, specify  1/5 (20.00%)  1
Vascular disorders   
Capillary leak syndrome  1/5 (20.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Monoclonal Antibody Therapy, Chemotherapy)
Affected / at Risk (%) # Events
Total   3/5 (60.00%)    
Blood and lymphatic system disorders   
Anemia  3/5 (60.00%)  3
Gastrointestinal disorders   
Mucositis oral  1/5 (20.00%)  1
Infections and infestations   
Infections and infestations - Other, specify  1/5 (20.00%)  1
Investigations   
Alanine aminotransferase increased  2/5 (40.00%)  2
Aspartate aminotransferase increased  1/5 (20.00%)  1
Blood bilirubin increased  1/5 (20.00%)  1
Neutrophil count decreased  1/5 (20.00%)  1
Platelet count decreased  2/5 (40.00%)  2
White blood cell decreased  2/5 (40.00%)  2
Metabolism and nutrition disorders   
Hypercalcemia  1/5 (20.00%)  1
Hyperglycemia  2/5 (40.00%)  2
Hypoalbuminemia  2/5 (40.00%)  2
Hypocalcemia  1/5 (20.00%)  1
Hypokalemia  2/5 (40.00%)  2
Hypomagnesemia  2/5 (40.00%)  2
Hyponatremia  1/5 (20.00%)  1
Hypophosphatemia  1/5 (20.00%)  1
Number of participants analyzed = 4. One patient was not evaluable for response. The Secondary Outcome measures will never be reported as data were not collected to assess these study aims.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 3522730558
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00354107     History of Changes
Other Study ID Numbers: NCI-2009-00407
NCI-2009-00407 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANHL06P1
CDR0000486425
ANHL06P1 ( Other Identifier: Children's Oncology Group )
ANHL06P1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: October 24, 2013
Results First Posted: January 1, 2014
Last Update Posted: March 14, 2018