SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or progressive (refractory) brain tumors

• Histologic confirmation waived for brainstem gliomas

• Bone marrow involvement allowed if transfusion independent

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• Lansky 60-100% OR

• Karnofsky 60-100%

Life expectancy:

• More than 8 weeks

Hematopoietic:

• See Disease Characteristics

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

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

• Hemoglobin greater than 9 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal

• SGPT and SGOT less than 2.5 times normal

• Albumin greater than 3 g/dL

• PT/PTT no greater than 120% upper limit of normal

• No overt hepatic disease

Renal:

• Creatinine no greater than 1.5 times normal OR

• Glomerular filtration rate greater than 70 mL/min

• No overt renal disease

Cardiovascular:

• No overt cardiac disease

Pulmonary:

• No overt pulmonary disease

Other:

• Neurologic deficits allowed if stable for at least 1 week prior to study

• More than 3rd percentile weight for height

• Able to swallow pills

• No uncontrolled infection

• No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for up to 10 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• More than 6 months since prior bone marrow transplantation

• More than 1 week since prior growth factors

Chemotherapy:

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

Endocrine therapy:

• Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study

• Concurrent oral contraceptives or other hormonal contraceptive methods allowed

Radiotherapy:

• More than 6 weeks since prior substantial bone marrow radiotherapy

• More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation

• More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites

Surgery:

• Not specified

Other:

• No concurrent enzyme-inducing anticonvulsant drugs

• No other concurrent anticancer or experimental drug therapy