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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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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.

Detailed Description

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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 recurrent or progressive medulloblastoma/primitive neuroectodermal tumor \[PNET\] vs 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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

tipifarnib

Intervention Type DRUG

Given orally

Interventions

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tipifarnib

Given orally

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maryam Fouladi

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Arcadia, California, United States

Site Status

Countries

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Australia Canada Netherlands New Zealand Puerto Rico Switzerland United States