SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

Pediatric Brain Tumor Consortium53 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

lonafarnibDRUG

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (9)

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers

Maximum tolerated dose of SCH 66336

Time frame: Four weeks

Pharmacokinetics of SCH 66336

Secondary Outcomes

Tumor response to SCH 66336

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.