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Home > "S" Clinical Trials Conditions > SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors  SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
For Condition: childhood meningioma,childhood brain tumor,childhood rhabdoid tumor of the central nervous system,childhood spinal cord tumors
Status: Recruiting
Sponsor(s): Pediatric Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of SCH 66336 in treating children who have recurrent or progressive brain tumors.
Details: OBJECTIVES: - Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors. - Determine the maximum tolerated dose of this drug in these patients. - Determine the pharmacokinetics of this drug with and without dexamethasone in these patients. - Determine 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 13 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 and then for up to 3 months. PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkKieran, Study Chair, Dana-Farber/Harvard Cancer Center
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0372
United States
Recruiting Michael Prados 415-353-2966
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting J. Geyer 206-987-6664
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting James Boyett 901-495-3370
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ian Pollack 412-692-5881
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Additional Information:
Study ID Numbers: CDR0000068571; SPRI-P02201,PBTC-003
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015899
Other Childhood Meningioma Studies:
1. SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
2. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
3. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
4. Antineoplaston Therapy in Treating Children With Rhabdoid Tumor of the Central Nervous System
5. Genetic Study of Brain Tumors in Young Children
Related Studies:
Other childhood meningioma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
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