Trials / Completed
CompletedNCT00006102
Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Brain and Central Nervous System Tumors
- Lymphoma
- Neuroblastoma
- Retinoblastoma
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | becatecarin |
Timeline
- Start date
- 2000-07-01
- Primary completion
- 2006-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-02-05
Locations
226 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland
Source: ClinicalTrials.gov record NCT00006102. Inclusion in this directory is not an endorsement.