Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors
NCT00112619 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2011-06-30
Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of topotecan when given by intraventricular infusion in treating young patients with neoplastic meningitis due to leukemia, lymphoma, or solid tumors.
Conditions
- Brain and Central Nervous System Tumors
- Carcinoma of Unknown Primary
- Leukemia
- Lymphoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
- DRUG
-
topotecan hydrochloride
Participants receive intraventricular topotecan, .2 mg, administered via an indwelling ventricular reservoir daily for 5 consecutive days during weeks 1 and 3 of the first four weeks of therapy (induction), during weeks 5 and 8 of the next 6 weeks of therapy (consolidation), and during weeks 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, and 51 (maintenance therapy).
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Pediatric Brain Tumor Consortium
lead NETWORK
Principal Investigators
-
Susan M. Blaney, MD · Baylor College of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2010-08-31
Countries
- United States
Study Locations
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