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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00070525
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maryam Fouladi
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Childhood High-grade Cerebral Astrocytoma, Childhood Oligodendroglioma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma
Additional Details

OBJECTIVES:

  • I. Determine the response rate in pediatric patients with recurrent or progressive high-grade glioma, medulloblastoma/primitive neuroectodermal tumor (PNET), or brain stem glioma treated with tipifarnib.
  • II. Determine the distribution of time to progression, time to treatment failure, and time to death in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (high-grade glioma vs.#46;recurrent or progressive medulloblastoma/primitive neuroectodermal tumor [PNET] vs.#46;progressive diffuse, intrinsic brain stem glioma). Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Arms & Interventions

Arms

Experimental: Arm I

Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Interventions

Drug: - tipifarnib

Given orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Oncology Group, Arcadia, California

Status

Address

Children's Oncology Group

Arcadia, California, 91006-3776

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