Busulfan in Treating Children and Adolescents With Refractory CNS Cancer

• 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 study the safety of delivering intrathecal busulfan in children and adolescents who have refractory CNS cancer and to estimate the maximum tolerated dose of this treatment regimen.

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

Details

• Lead Sponsor: Pediatric Brain Tumor Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed CNS malignancy, including any of the following:

• Primary malignant brain tumor refractory to standard therapy and metastatic to the cerebrospinal fluid (CSF) or leptomeningeal subarachnoid space

• Recurrent or persistent leptomeningeal leukemia, lymphoma, or germ cell tumor refractory to conventional therapy

• In second or greater relapse

• CSF white blood count greater than 5 cells/mm3 with blasts on cytospin OR

• Evidence of leptomeningeal tumor by MRI

• No concurrent bone marrow disease

• No obstruction or compartmentalization of CSF flow on CSF flow study

PATIENT CHARACTERISTICS:

Age:

• 3 to 21

Performance status:

• Lansky 50-100% (under 10 years)

• Karnofsky 50-100% (10 to 21 years)

Life expectancy:

• Greater than 8 weeks

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 75,000/mm^3

Hepatic:

• Bilirubin normal for age

• ALT and AST less than 5 times upper limit of normal (ULN)

• No hepatic disease

Renal:

• Creatinine no greater than 1.5 times ULN OR

• Glomerular filtration rate greater than 70 mL/min

• No renal disease

Cardiovascular:

• No cardiac disease

Pulmonary:

• No pulmonary disease

Other:

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

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

• Evidence of subsequent disease progression

• Concurrent systemic chemotherapy allowed for recurrent disease after first course of treatment except for the following:

• Chemotherapy targeted at leptomeningeal disease

• Other phase I agent

• Any agent that significantly penetrates the CSF (e.g., high dose methotrexate greater than 1 g/m2, thiotepa, high dose cytarabine, fluorouracil, IV mercaptopurine, nitrosoureas, or topotecan)

• Any agent that causes serious unpredictable CNS side effects

Endocrine therapy:

• Prior dexamethasone allowed with decreasing or stable dose at least one week before study

• Concurrent dexamethasone or prednisone with chemotherapy regimen allowed

Radiotherapy:

• At least 1 week since prior focal irradiation to the brain or spine

• At least 8 weeks since prior craniospinal irradiation

• No concurrent cranial or craniospinal irradiation

Surgery:

• Not specified

Other:

• No other concurrent intrathecal or systemic therapy for leptomeningeal disease