Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00058097 | Completed Phase 2

• 4 other identifiers: NCI-2012-03013NABTT 2200CDR285732U01CA062475
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of combining tipifarnib with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining tipifarnib with radiation therapy may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  95% confidence intervals will be estimated.

  Up to 5 years

Secondary Outcomes (3)

• Response rate

  Up to 5 years

• Progression free survival

  Up to 5 years

• Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v4.0

  Up to 5 years

Study Arms (1)

Treatment (tipifarnib)

EXPERIMENTAL

INDUCTION THERAPY: Patients receive oral tipifarnib twice daily for 3 weeks. Treatment repeats every 4 weeks for up to 3 courses. RADIOTHERAPY: Within 14 days after the completion of induction therapy, patients undergo radiotherapy daily, 5 days a week, for 6 weeks. MAINTENANCE THERAPY: Two weeks after the completion of radiotherapy, patients receive additional tipifarnib as in induction therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: tipifarnib; Radiation: radiation therapy

Interventions

tipifarnib DRUG

Given orally

Also known as: R115777, Zarnestra

Treatment (tipifarnib)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (tipifarnib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
• Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
• Patients must have measurable and contrast-enhancing tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment)
• Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment
• Patients must have a Karnofsky performance status \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
• Absolute neutrophil count \>= 1500/mm\^3
• Platelets \>= 100,000/mm\^3
• Hemoglobin \>= 9 g/dl
• Creatinine =\< 1.5 mg/dl
• Total bilirubin =\< 2.0 mg/dl
• Transaminases =\< 4 times above the upper limits of the institutional norm
• Patients must be able to provide written informed consent and must be aware of the investigational nature of this study
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant; female patients of child-bearing potential must have a negative pregnancy test
• Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast; patients with prior malignancies must be disease-free for \>= five years
• Patients must have a mini-mental state exam score (MMSE) of \>= 15

You may not qualify if:

• Patients with serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety
• Patients who are pregnant or breast-feeding
• Patients who have received prior radiation therapy, chemotherapy, hormonal therapy (except glucocorticoids), immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy) for their brain tumor
• Patients receiving concurrent investigational agents
• Patients who have received Gliadel wafer therapy may not participate in this study

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

New Approaches to Brain Tumor Therapy Consortium

Baltimore, Maryland, 21231-1000, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

tipifarnib; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Robert Lustig

  New Approaches to Brain Tumor Therapy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: August 1, 2003
• Primary Completion: January 1, 2007
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

US (1)