Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354107
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2006-07-19
Brief Title:
Ifosfamide Carboplatin Etoposide and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Pilot Study of Ifosfamide Carboplatin and Etoposide Therapy ICE and SGN-30 NSC 731636 IND in Children With CD30 Recurrent Anaplastic Large Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial is studying the side effects and best dose of SGN-30 when given together with ifosfamide carboplatin and etoposide and to see how well they work in treating young patients with recurrent anaplastic large cell lymphoma Drugs used in chemotherapy such as ifosfamide carboplatin and etoposide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as SGN-30 can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them
Detailed Description:
PRIMARY OBJECTIVES
I Define and describe the toxicities of monoclonal antibody SGN-30 alone window and in combination with ifosfamide carboplatin and etoposide ICE in pediatric patients with CD30-positive recurrent anaplastic large cell lymphoma
II Define preliminarily the antitumor activity of monoclonal antibody SGN-30 alone window and in combination with ICE in these patients
SECONDARY OBJECTIVES
I Characterize the pharmacokinetics of monoclonal antibody SGN-30 in these patients
II Characterize the soluble CD30 concentrations at time of relapse in these patients
III Characterize the development of human antichimeric antibodies in these patients
IV Measure minimal residual disease in these patients
OUTLINE This is a multicenter pilot phase I dose-finding study of monoclonal antibody SGN-30 followed by a phase II study
Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8 Beginning in week 5 patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3 carboplatin IV over 1 hour on day 1 and etoposide IV 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 comprising methotrexate cytarabine and hydrocortisone once on day 29 week 5
NOTE Patients planning to undergo bone marrow transplantation BMT receive 2 courses of ICE only and then undergo BMT off study
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 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
After completion of study treatment patients are followed periodically for 5 years
I Define and describe the toxicities of monoclonal antibody SGN-30 alone window and in combination with ifosfamide carboplatin and etoposide ICE in pediatric patients with CD30-positive recurrent anaplastic large cell lymphoma
II Define preliminarily the antitumor activity of monoclonal antibody SGN-30 alone window and in combination with ICE in these patients
SECONDARY OBJECTIVES
I Characterize the pharmacokinetics of monoclonal antibody SGN-30 in these patients
II Characterize the soluble CD30 concentrations at time of relapse in these patients
III Characterize the development of human antichimeric antibodies in these patients
IV Measure minimal residual disease in these patients
OUTLINE This is a multicenter pilot phase I dose-finding study of monoclonal antibody SGN-30 followed by a phase II study
Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8 Beginning in week 5 patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3 carboplatin IV over 1 hour on day 1 and etoposide IV 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 comprising methotrexate cytarabine and hydrocortisone once on day 29 week 5
NOTE Patients planning to undergo bone marrow transplantation BMT receive 2 courses of ICE only and then undergo BMT off study
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 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
After completion of study treatment patients are followed periodically for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00407 | REGISTRY | None | None |
| COG-ANHL06P1 | None | None | None |
| CDR0000486425 | None | None | None |
| ANHL06P1 | OTHER | None | None |
| ANHL06P1 | OTHER | None | None |