Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

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.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant