NCT00005811

Topotecan Hydrochloride in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment

A Phase II Study of Intrathecal Topotecan (NSC #609699) in Patients With Refractory Meningeal Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment

Detailed description

PRIMARY OBJECTIVES: I. Determine the therapeutic activity of intrathecal topotecan, in terms of response rate and time to central nervous system (CNS) progression, in pediatric patients with recurrent or refractory neoplastic meningitis. II. Determine the safety and toxicity of this regimen in these patients. III. Evaluate the concentration of matrix metalloproteinases (MMPs) in the cerebrospinal fluid (CSF) of these patients. 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) INDUCTION: Patients receive topotecan hydrochloride intrathecally (IT) over 5 minutes twice weekly for 6 weeks. CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1. After completion of study treatment, patients are followed up 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.

Conditions

• AIDS-related Diffuse Large Cell Lymphoma
• AIDS-related Diffuse Mixed Cell Lymphoma
• AIDS-related Diffuse Small Cleaved Cell Lymphoma
• AIDS-related Immunoblastic Large Cell Lymphoma
• AIDS-related Lymphoblastic Lymphoma
• AIDS-related Peripheral/Systemic Lymphoma
• AIDS-related Primary CNS Lymphoma
• AIDS-related Small Noncleaved Cell Lymphoma
• Childhood Diffuse Large Cell Lymphoma
• Childhood Immunoblastic Large Cell Lymphoma
• HIV-associated Hodgkin Lymphoma
• Leptomeningeal Metastases
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Recurrent Childhood Large Cell Lymphoma
• Recurrent Childhood Lymphoblastic Lymphoma
• Recurrent Childhood Medulloblastoma
• Recurrent Childhood Small Noncleaved Cell Lymphoma
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	topotecan hydrochloride	Given IT
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-04-01
• Primary completion: 2006-04-01
• Completion: 2009-02-01
• First posted: 2003-01-27
• Last updated: 2013-02-21

Locations

1 site across 1 country: United States