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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006102 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Lymphoma Neuroblastoma Retinoblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: becatecarin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors |
| Study Start Date: | July 2000 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 100-200 patients will be accrued for this study within 2.4 months to 2.5 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors
CNS/brain tumors:
Histologically or cytologically proven non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent use of the following foods or medications:
Contacts and Locations
Show 226 Study Locations| Study Chair: | Anne-Marie Langevin, MD | University of Texas |
More Information
| Study ID Numbers: | CDR0000068111, COG-P9963 |
| Study First Received: | August 3, 2000 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006102 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma childhood craniopharyngioma disseminated neuroblastoma recurrent neuroblastoma intraocular retinoblastoma extraocular retinoblastoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma childhood central nervous system germ cell tumor unspecified childhood solid tumor, protocol specific childhood high-grade cerebral astrocytoma childhood oligodendroglioma |
childhood choroid plexus tumor childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma stage III childhood large cell lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent childhood brain stem glioma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood visual pathway and hypothalamic glioma |
|
Retinal Neoplasms Choroid Plexus Neoplasms Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Retinoblastoma Lymphoblastic Lymphoma Neuroblastoma Ependymoma Lymphoma, Small Cleaved-cell, Diffuse Soft Tissue Sarcomas Neoplasms, Germ Cell and Embryonal Craniopharyngioma Neuroepithelioma Meningioma Glioma |
Lymphoma, Large-cell Lymphoma Retinal Diseases Nervous System Neoplasms Rhabdomyosarcoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Eye Neoplasms Astrocytoma Eye Diseases Rhabdomyosarcoma, Childhood Small Non-cleaved Cell Lymphoma Recurrence Neuroectodermal Tumors Lymphatic Diseases |
|
Retinal Neoplasms Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Immunoproliferative Disorders Eye Neoplasms Immune System Diseases Eye Diseases Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Retinoblastoma Neuroblastoma |
Neuroectodermal Tumors Lymphatic Diseases Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Lymphoproliferative Disorders Lymphoma Retinal Diseases Neuroectodermal Tumors, Primitive, Peripheral Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
