O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors

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

Summary

Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carmustine; O(6)-benzylguanine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven CNS tumor that is refractory to conventional therapy or for which no effective therapy is known

• Histological requirement may be waived for brainstem and optic gliomas

• Stratum 2: No bone marrow involvement

PATIENT CHARACTERISTICS:

• Age: 21 and under

• Performance status: Karnofsky 50-100% OR Lansky 50-100%

• Life expectancy: At least 8 weeks

• Absolute neutrophil count at least 1500/mm3

• Platelet count at least 100,000/mm3 (stratum 2: at least 125,000/mm3)

• Hemoglobin at least 8 g/dL

• Bilirubin less than 1.5 mg/dL

• SGOT/SGPT no greater than 2.5 times normal

• Creatinine or GFR normal for age

• If required, DLCO must be 80% of normal and patient old enough to cooperate for DLCO test

• Neurologic deficits must be stable for at least 2 weeks prior to study

• Not pregnant or nursing

• Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

• At least 7 days since prior biologic therapy or immunotherapy and recovered

• At least 6 months since prior bone marrow transplant (stratum 1 only)

• At least 7 days since prior growth factors

• No concurrent filgrastim (G-CSF) prophylaxis

• Stratum 2: No prior bone marrow transplantation

• At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) and recovered

• Stratum 2: No greater than 2 prior chemotherapy regimens

• No prior nitrosourea therapy

• If receiving dexamethasone, must be on stable or decreasing dose for at least 2 weeks prior to study

• At least 2 weeks since prior local palliative radiotherapy (small port)

• At least 6 months since prior substantial bone marrow radiation, total body irradiation, hemipelvic radiotherapy, or total abdominal/pelvic/chest or mantle/Y ports radiotherapy

• Recovered from prior radiotherapy

• Stratum 2: No prior central axis radiation

• No other concurrent anticancer or investigational agents