Expired Study
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Memphis, Tennessee 38105


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.

Study summary:

OBJECTIVES: - Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors. - Estimate the maximum tolerated dose of this drug in these patients. - Describe the pharmacokinetics of this drug with and without dexamethasone in these patients. - Investigate the efficacy of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD. Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.


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



Primary Contact:

Study Chair
Mark W. Kieran, MD, PhD
Dana-Farber Cancer Institute

Backup Contact:


Location Contact:

Memphis, Tennessee 38105
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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