Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologic or tumor marker confirmation of malignancy at original diagnosis

• Neoplastic meningitis/leptomeningeal metastasis refractory to conventional therapy and other therapies of higher priority, defined as:

• Stratum A:

• Small non-cleaved lymphoma (Burkitt's) with any L-3 blast in cerebrospinal fluid (CSF)

• Any other lymphoma or leukemia with CSF cell count greater than 5/mm3 AND evidence of blast cells by cytology or cytospin preparation OR

• Stratum B:

• Solid tumor or other malignancy with presence of tumor cells on cytospin OR positive cytology OR neuroimaging evidence of leptomeningeal tumor by MRI or CT myelogram

• No leptomeningeal leukemia or lymphoma with concurrent bone marrow relapse

• No clinical evidence of untreated obstructive hydrocephalus or compartmentalization of the CSF

PATIENT CHARACTERISTICS:

Age:

• 65 and under

Performance status:

• Lansky 50-100% (age 16 and under)

• Karnofsky 50-100% OR ECOG 0-3 (over age 16)

Life expectancy:

• At least 2 months

Hematopoietic:

• Stratum B:

• Absolute neutrophil count at least 750/mm^3

• Platelet count at least 75,000/mm^3 (transfusion independent)

• Hemoglobin at least 10.0 g/dL (red blood cell transfusions allowed)

Hepatic:

• Bilirubin no greater than 1.5 times normal

• SGOT or SGPT less than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Neurologic:

• Seizures allowed if well controlled and on anticonvulsants

• CNS toxicity no greater than grade 2

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infections

• HIV allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunomodulating agents (stratum B)

• No stem cell transplantation (stratum A)

Chemotherapy:

• At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas)

• No other concurrent cancer chemotherapy (stratum B)

• Other concurrent systemic cancer chemotherapy for leukemia or lymphoma allowed with the following restrictions:

• No oral or IV topotecan

• No moderate or high-dose IV or subcutaneous cytarabine (greater than 1.0 g/m2 per day)

• No moderate or high-dose IV methotrexate (greater than 1 g/m2 per day)

• No IV thiotepa

• No myeloablative chemotherapy

• No intrathecal or intraventricular chemotherapy

Endocrine therapy:

• Concurrent corticosteroids allowed only for treatment of increased intracranial pressure in patients with CNS tumors

• No concurrent intrathecal or intraventricular hydrocortisone

Radiotherapy:

• At least 4 weeks since completion of radiotherapy to the brain or spine and recovered

• Concurrent radiotherapy to localized painful lesions producing acute neurologic dysfunction allowed provided at least 1 measurable lesion is not irradiated

• No concurrent craniospinal or whole-brain radiotherapy

Surgery:

• Not specified

Other:

• Recovered from prior therapy

• At least 7 days since prior investigational drug

• No other concurrent intrathecal or intraventricular therapy for leptomeningeal disease