Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005811 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well topotecan works in treating children with meningeal cancer that has not responded to previous treatment.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Leukemia Lymphoma Metastatic Cancer Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Intrathecal Topotecan (NSC #609699) in Patients With Refractory Meningeal Malignancies |
Estimated Enrollment: | 77 |
Study Start Date: | April 2000 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease type (acute lymphoblastic leukemia vs other leukemia/lymphoma vs medulloblastoma vs other solid tumors). (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
Patients are followed monthly for 3 months, every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-77 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven refractory leukemia, lymphoma, or other solid tumor that has overt meningeal involvement (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
Definition of meningeal disease:
Leukemia/lymphoma (including acute lymphoblastic leukemia)
Solid tumors (including medulloblastoma)
No clinical evidence of obstructive hydrocephalus or compartmentalization of CSF flow as documented by radioisotope indium In 111 or technetium Tc 99 DTPA flow study
No ventriculoperitoneal or ventriculoatrial shunt unless:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
At least 7 days since prior investigational drug
Study Chair: | Susan M. Blaney, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000067813, COG-P9962, POG-9962, CCG-P9962, NCI-01-C-0123 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005811 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma unspecified childhood solid tumor, protocol specific recurrent/refractory childhood Hodgkin lymphoma leptomeningeal metastases AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma |
AIDS-related diffuse large cell lymphoma AIDS-related immunoblastic large cell lymphoma AIDS-related small noncleaved cell lymphoma HIV-associated Hodgkin lymphoma AIDS-related diffuse mixed cell lymphoma AIDS-related diffuse small cleaved cell lymphoma AIDS-related lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent childhood medulloblastoma |
Leukemia, Lymphoid Hodgkin's disease Lymphoma, small cleaved-cell, diffuse Central Nervous System Neoplasms Leukemia, Myeloid, Acute Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Lymphoma, large-cell Leukemia Lymphoma, Large-Cell, Immunoblastic Neoplasm Metastasis Hodgkin Disease Lymphoma Acute myelocytic leukemia |
Nervous System Neoplasms Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Acquired Immunodeficiency Syndrome Acute myelogenous leukemia Lymphoblastic lymphoma Leukemia, Myeloid Recurrence Lymphatic Diseases HIV Infections Hodgkin lymphoma, childhood Medulloblastoma Topotecan Lymphoma, Non-Hodgkin |
Neoplastic Processes Neoplasms Neoplasms by Site Pathologic Processes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Immune System Diseases Antineoplastic Agents Therapeutic Uses Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |