Status:
COMPLETED
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Untreated Childhood Brain Stem Glioma
Eligibility:
All Genders
3-21 years
Phase:
PHASE1
PHASE2
Brief Summary
Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more ...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) of R115777 administered concurrently with radiation therapy to pediatric patients with non-disseminated, diffuse, intrinsic brainst...
Eligibility Criteria
Inclusion
- Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma
- Karnofsky performance scale (KPS) (for \> 16 yrs of age) or Lansky performance score (LPS) (for =\< 16 years of age) =\> 50 assessed within two weeks prior to registration
- Prior/concurrent therapy:
- Chemo: No prior therapy allowed
- Radiation therapy (XRT): No prior therapy allowed
- Bone Marrow Transplant: None prior
- Anti-convulsants: Patients receiving EIACDs will not be eligible; however, patients may switch from EIACDs to non-EIACDs and must then be on non-EIACDs for a minimum of 7 days prior to registration
- Growth factors: Off all colony forming growth factor(s) \> 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin)
- Absolute neutrophil count \>= 1,000/mm\^3
- Platelets \>= 100,000/mm\^3 (transfusion independent)
- Hemoglobin \>= 8 gm/dL (transfusion independent)
- Serum creatinine that is less than the upper limit of institutional normal for age or GFR \> 70 ml/min/1.73m2
- Bilirubin =\< 1.5 time upper limit of normal for age
- SGPT (ALT) and SGOT (AST) \< 2.5 times institutional upper limit of normal
- Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding
- Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
- Signed informed consent according to institutional guidelines must be obtained
Exclusion
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
- Patients with disseminated intrinsic diffuse brainstem glioma
- Patients taking enzyme-inducing anticonvulsant drugs
- Patients with known allergy to topical or systemic imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole)
- Patients receiving any other anticancer or experimental drug therapy
- Patients with uncontrolled infection
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00079339
Start Date
January 1 2004
End Date
November 1 2009
Last Update
May 15 2014
Active Locations (1)
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1
Pediatric Brain Tumor Consortium
Memphis, Tennessee, United States, 38105