Overview

Tipifarnib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial is studying the side effects and best dose of tipifarnib when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib, temozolomide, and radiation therapy may kill more tumor cells.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Dacarbazine
Temozolomide
Tipifarnib
Criteria
Inclusion Criteria:

- Patients will have histologically proven intracranial Glioblastoma Multiforme (GBM) or
gliosarcoma (GS)

- Diagnosis will have been established by biopsy or resection within 4 weeks prior to
registration

- Patients must not have received previous radiotherapy to the brain

- Patients must not have received cytotoxic drug therapy, non-cytotoxic drug therapy, or
experimental drug therapy directed against the brain tumor; patients who received
Gliadel wafers will be excluded; patients may have received or be receiving
corticosteroids, non-EIAEDs, analgesics, and other drugs to treat symptoms or prevent
complications

- Cranial MRI or contrast CT must have been performed within 21days of study entry; the
use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT must be
used throughout the period of protocol treatment for tumor measurement; if the
surgical procedure was a resection, cranial MRI or contrast CT performed with 96 hours
of resection is preferred but not required; patients without measurable or assessable
disease are eligible

- Patients must have a plan to begin partial brain radiotherapy within 5-9 days after
beginning R115777, and within 35 days (5 weeks) of the surgical procedure that
established the diagnosis; radiotherapy must be given at the Radiation Oncology
Department of the registering ABTC institution; radiotherapy must be given by external
beam to a partial brain field in daily fractions of 2.0 Gy, to a planned total dose to
the tumor of 60.0 Gy; stereotactic radiosurgery and brachytherapy will not be allowed

- Patients must be willing to forego other drug therapy against the tumor while being
treated with R115777 and temozolomide

- All patients must sign an informed consent indicating that they are aware of the
investigational nature of this study; patients must sign an authorization for the
release of their protected health information; patients must be registered with the
Adult Brain Tumor Consortium Central Office (ABTC CO) prior to treatment with study
drug

- Life expectancy > 8 weeks

- Patients must have a Karnofsky performance status of >= 60

- Patients must have adequate bone marrow function and the test must be performed within
14 days prior to registration; eligibility level for hemoglobin may be reached by
transfusion

- WBC >= 3,000/µl

- ANC >= 1,500/mm^3

- Platelet count of >= 100,000/mm^3

- Hemoglobin >= 10 gm/dl

- Patients must have adequate liver function and the test must be performed within 14
days prior to registration

- SGOT < 2 times ULN

- Bilirubin < 2 times ULN

- Patients must have adequate renal function before starting therapy and the test must
be performed within 14 days prior to registration

- Creatinine < 1.5 mg/dL

- 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 a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix), unless in complete remission and off of all therapy
for that disease for a minimum of 3 years are ineligible

- This study was designed to include women and minorities, but was not designed to
measure differences of intervention effects; males and females will be recruited with
no preference to gender; no exclusion to this study will be based on race; minorities
will actively be recruited to participate

- Patients must not have active infection

- Women must not be pregnant or Breast-feeding, and women with reproductive potential
must practice adequate contraception; the anti-proliferative effects of the
investigational agent may be detrimental to the developing fetus or nursing infant

- Patients must not be on chronic coumadin therapy for prior medical problems (e.g.
cardiac valve prophylaxis); this is due to a presumed interaction with coumadin and
ZARNESTRA leading to a significant increase in INR; patients who develop or have
recently developed a deep venous thrombosis or pulmonary embolism who are on or will
take coumadin will be allowed to participate; however, the investigator should be
prepared to monitor patients INR closely