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

Completed · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT00005811

Run by

National Cancer Institute (NCI)

People needed

77

Starts

2000-04-01

Expected to finish

2009-02-01

Last updated by the study team

2013-02-21

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven refractory leukemia, lymphoma, or other solid tumor thathas 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)
• CSF cell count greater than 5/mm\^3 AND evidence of blast cells oncytospin preparation or by cytology
• Refractory to conventional therapy, including radiotherapy (i.e., in second or greater relapse)
• No concurrent bone marrow relapse
• Solid tumors (including medulloblastoma)
• Presence of tumor cells on cytospin preparation or cytology OR presence ofmeningeal disease on MRI scans
• No clinical evidence of obstructive hydrocephalus or compartmentalization ofCSF flow as documented by radioisotope indium In 111 or technetium Tc 99 DTPAflow study
• If CSF flow block is demonstrated, focal radiotherapy must be administered tosite of block to restore flow and a repeat CSF flow study must show clearing of blockage
• No ventriculoperitoneal or ventriculoatrial shunt unless:
• Patient is shunt independent and there is evidence that the shunt is nonfunctional
• CSF flow study demonstrates normal flow
• No impending cord compression, CNS involvement requiring local radiotherapy(e.g., optic nerve), or isolated bulky ventricular or leptomeningeal basedlesions
• Performance status - Lansky 50-100% (age 10 and under)
• Performance status - Karnofsky 50-100% (over age 10)
• At least 8 weeks
• Platelet count greater than 40,000/mm\^3 (transfusions allowed)
• Bilirubin less than 2.0 mg/dL
• SGPT less than 5 times normal
• Creatinine less than 1.5 mg/dL
• Electrolytes, calcium, and phosphorus normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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