Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor, or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Tipifarnib

Criteria

Inclusion Criteria:

• Histologically confirmed brain tumor, including the following:

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic oligodendroglioma

• Medulloblastoma/primitive neuroectodermal tumor (PNET)

• Diffuse intrinsic brain stem glioma*

• Progressive or relapsed disease after prior conventional therapy

• Radiographic evidence of measurable disease

• Performance status - Karnofsky 60-100% (over 16 years of age)

• Performance status - Lansky 60-100% (16 years of age and under)

• Performance status - ECOG 0-2

• At least 8 weeks

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3 (transfusion independent)

• Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGPT and SGOT less than 2.5 times ULN

• Creatinine clearance OR radioisotope glomerular filtration rate at least 70 mL/min

• Maximum creatinine based on age as follows:

• 0.8 mg/dL (5 years and under)

• 1.0 mg/dL (6 to 10 years)

• 1.2 mg/dL (11 to 15 years)

• 1.5 mg/dL (over 15 years)

• Shortening fraction at least 27% by echocardiogram

• Ejection fraction at least 50% by MUGA

• No dyspnea at rest

• No exercise intolerance

• Pulse oximetry greater than 94%*

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Seizure disorder is allowed provided it is well-controlled on non-enzyme-inducing anticonvulsants

• No active graft-versus-host disease

• No uncontrolled infection

• No allergy to azoles (e.g., ketoconazole, itraconazole, or fluconazole)

• Recovered from prior immunotherapy

• At least 7 days since prior antineoplastic biologic agents

• At least 1 month since prior autologous stem cell transplantation (SCT)

• At least 6 months since prior allogeneic SCT

• More than 1 week since prior growth factors

• No concurrent immunomodulating agents

• More than 2 weeks since prior myelosuppressive chemotherapy (4-6 weeks for nitrosoureas or temozolomide) and recovered

• No concurrent anticancer chemotherapy

• Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for at least 1 week prior to study entry

• Concurrent corticosteroids allowed only for treatment of increased intracranial pressure

• Recovered from prior radiotherapy

• At least 2 weeks since prior local palliative radiotherapy (small port)

• At least 3 months since prior craniospinal radiotherapy

• At least 6 weeks since other prior substantial bone marrow radiotherapy

• No concurrent palliative radiotherapy

• No prior initiation of therapy on another phase II study

• No concurrent participation in another therapeutic COG study

• No concurrent enzyme-inducing anticonvulsants

• No other concurrent anticancer or experimental drugs

• No concurrent foods or medications that interfere with CYP3A4, including any of the following:

• Carbamazepine

• Phenytoin

• Phenobarbital

• Grapefruit juice

• Erythromycin

• Azithromycin

• Clarithromycin

• Rifampin and its analogues

• Fluconazole

• Ketoconazole

• Itraconazole

• Cimetidine

• Cannabinoids (i.e., marijuana or dronabinol)

• Omeprazole

• Hypericum perforatum (St. John's wort)

• Ethosuximide

• Glucocorticoids

• Griseofulvin

• Nafcillin

• Nelfinavir

• Norfloxacin

• Norfluoxetine

• Nevirapine

• Oxcarbazepine

• Phenylbutazone

• Primidone

• Progesterone (all progestins)

• Rifabutin

• Rofecoxib

• Sulfadimidine

• Sulfinpyrazone

• Troglitazone

• Rifapentine

• Modafinil

• Amiodarone

• Anastrozole

• Clotrimazole

• Cyclosporine

• Danazol

• Delavirdine

• Diethyldithiocarbamate

• Diltiazem

• Dirithromycin

• Disulfiram

• Entacapone (high dose)

• Ethinyl estradiol

• Fluoxetine

• Fluvoxamine

• Gestodene

• Indinavir

• Isoniazid

• Metronidazole

• Mibefradil

• Miconazole

• Nefazodone

• Oxiconazole

• Paroxetine

• Propoxyphene

• Roxithromycin

• Quinidine

• Quinine

• Quinupristin and dalfopristin

• Ranitidine

• Ritonavir

• Saquinavir

• Sertindole

• Sertraline

• Troleandomycin

• Valproic acid

• Verapamil

• Voriconazole

• Zafirlukast

• Zileuton