Phase I Study of Intrathecal Topotecan

NCT00001333•National Cancer Institute (NCI)

Summary

Detailed Description

The purpose of this study is to determine the qualitative and quantitative toxicity of intrathecal topotecan, a topoisomerase I inhibitor, in patients with meningeal malignancies refractory to conventional therapy (radiation therapy and chemotherapy). A safe dose of topotecan that can be recommended for intrathecal administration in subsequent phase II studies will be established in a limited dosage escalation schedule. The CSF pharmacokinetics of intrathecal topotecan will also be studied. Topotecan will be administered intrathecally on a bi-weekly basis for four to six weeks, followed by weekly administration for 1 month, twice monthly administration for four months and then monthly IT administration.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Leukemia, lymphoma, or solid tumor with overt meningeal involvement considered refractory to conventional therapy.
•CSF leukemic cell count at least 5 per cubic millimeter with evidence of blast cells on cytospin or cytology required for leukemia and lymphoma patients.
•Tumor cells on cytospin or cytology or measurable meningeal disease on CT or MRI required for patients with solid tumors.
•No clinical evidence of obstructive hydrocephalus or compartmentalization of the CSF flow as documented by indium-111- or technetium-99-DPTA flow study.
•PRIOR/CONCURRENT THERAPY:
•At least 1 week since CNS therapy.
•Biologic Therapy: Recovery from toxic effects of prior immunotherapy required.
•Chemotherapy:
•Recovery from toxic effects of prior chemotherapy required.
+14 more criteria

Locations (1)

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Key Dates

Start Date

February 1, 1993

Completion Date

December 1, 2000

Last Updated

March 4, 2008

Enrollment

Estimated participants

Conditions

LeukemiaLymphomaMeningeal Neoplasms

Interventions

topotecan

DRUG

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RECRUITINGPHASE2/PHASE3

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DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Phase I Study of Intrathecal Topotecan

Inclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Phase I Study of HC-7366 for Acute Myeloid Leukemia