Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors

• Status: Completed
• Trial end date: 2001-02-01
• 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. Giving drugs into the thin space between the lining of the spinal cord and brain may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of intrathecal busulfan in treating patients with recurrent, refractory, or metastatic leptomeningeal tumors.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed neoplasm that is metastatic in the cerebrospinal fluid or leptomeningeal/subarachnoid space

• Cytologic diagnosis of malignancy in the cerebrospinal fluid or neuroimaging evidence of leptomeningeal tumor by MRI

• Must have a recurrent or refractory leptomeningeal tumor

• Leptomeningeal tumors of leukemia, lymphoma, and all germ cell tumors must have also failed initial treatment or be recurrent

• No evidence of obstructive hydrocephalus or complete block of the spinal cerebrospinal fluid pathways on prestudy technetium Tc 99m albumin or indium In 111 DTPA flow study

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.5 mg/dL

• SGOT or SGPT less than 1.5 times normal

Renal:

• BUN less than 30 mg/dL

• Creatinine less than 1.5 mg/dL

• Calcium within normal limits

Neurological:

• Neurological examination stable

• No rapidly progressing or deteriorating neurological deficits

Other:

• No active infectious process

• Magnesium, phosphorus, potassium, chloride, and bicarbonate normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

Chemotherapy:

• At least 6 weeks since prior nitrosoureas or mitomycin

• At least 4 weeks since any other prior chemotherapy

• At least 3 weeks since prior intrathecal chemotherapy

• No other concurrent intrathecal chemotherapy

Endocrine therapy:

• For patients on corticosteroids:

• Must be on a stable dose of corticosteroids for at least 1 week

Radiotherapy:

• At least 3 weeks since prior radiotherapy to the CNS

• At least 4 weeks since any other prior radiotherapy

• No concurrent radiotherapy to the CNS

Surgery:

• At least 3 weeks since prior surgery

Other:

• No concurrent medication that may interfere with study results (e.g., immunosuppressive agents other than corticosteroids)