Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors

• 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 tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Mafosfamide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm^3 AND evidence of blast cells on cytospin preparation or by cytology OR

• Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan

• Meningeal malignancy must be progressive or refractory to conventional therapy

• Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy

• No concurrent bone marrow relapse in leukemia or lymphoma patients

• No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study

• Patients demonstrating restored flow after focal radiotherapy are allowed

PATIENT CHARACTERISTICS:

Age:

• Over 3

Performance status:

• ECOG 0-2

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Not specified

Hepatic:

• No clinically significant liver function abnormalities

Renal:

• No clinically significant renal function abnormalities

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

• No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus)

• No significant systemic illness (e.g., infection)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Recovered from prior immunotherapy

Chemotherapy:

• At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered

• Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions:

• No phase I agent

• No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m^2), high-dose cytarabine (more than 2 g/m^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa)

• No agent known to have serious unpredictable CNS side effects

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• Recovered from prior radiotherapy

• At least 8 weeks since prior craniospinal irradiation

• Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy

• No concurrent whole brain or craniospinal irradiation

• Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed

• Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances

Surgery:

• Not specified

Other:

• At least 1 week since any prior CNS therapy

• At least 7 days since prior intrathecal investigational agent

• At least 14 days since prior systemic investigational agent

• No other concurrent intrathecal or systemic investigational agent

• No other concurrent intrathecal or systemic therapy to treat meningeal malignancy

• No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier

• No concurrent agent known to have serious unpredictable CNS side effects