Clinical trial · Interventional
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
NCT00015899CI-TRIAL-00002698completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lonafarnib | Drug | Lonafarnib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers
- measure
- Maximum tolerated dose of SCH 66336
- timeFrame
- Four weeks
- measure
- Pharmacokinetics of SCH 66336
Secondary outcomes (1)
- measure
- Tumor response to SCH 66336
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE. Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2007 Jul 20;25(21):3137-43. doi: 10.1200/JCO.2006.09.4243. PMID 17634493