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Clinical Trials/NCT00006102
NCT00006102
Completed
Phase 2

A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

National Cancer Institute (NCI)225 sites in 1 country200 target enrollmentJuly 2000
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ConditionsBrain and Central Nervous System TumorsLymphomaNeuroblastomaRetinoblastomaSarcomaUnspecified Childhood Solid Tumor, Protocol Specific
Interventionsbecatecarin
Drugsbecatecarin

Overview

Phase
Phase 2
Intervention
becatecarin
Conditions
Brain and Central Nervous System Tumors
Sponsor
National Cancer Institute (NCI)
Enrollment
200
Locations
225
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Detailed Description

OBJECTIVES: I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated with rebeccamycin analogue. II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these patients. III. Determine the toxicity of this drug in these patients. IV. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma \[closed to accrual as of 5/19/03\]/peripheral primative neuroectodermal tumor \[PNET\] vs osteosarcoma \[closed to accrual as of 5/19/03\] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors). Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Registry
clinicaltrials.gov
Start Date
July 2000
End Date
June 2006
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm I

Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs Ewing's sarcoma \[closed to accrual as of 5/19/03\]/peripheral primative neuroectodermal tumor \[PNET\] vs osteosarcoma \[closed to accrual as of 5/19/03\] vs rhabdomyosarcoma vs non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs other CNS tumors). Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21 days for a total of 16 courses in the absence of disease progression or unacceptable toxicity.

Intervention: becatecarin

Outcomes

Primary Outcomes

Not specified

Study Sites (225)

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