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

Primary Purpose

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tipifarnib
radiation therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Giant Cell Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • New Approaches to Brain Tumor Therapy Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (tipifarnib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival
95% confidence intervals will be estimated.

Secondary Outcome Measures

Response rate
Estimated with 95% confidence intervals.
Progression free survival
Estimated with 95% confidence intervals.
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v4.0

Full Information

First Posted
April 7, 2003
Last Updated
April 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058097
Brief Title
Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate overall survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before (and possibly after) radiation therapy. SECONDARY OBJECTIVES: I. To estimate response rate in adult patients with newly diagnosed glioblastoma multiforme treated with R115777 prior to therapy with radiation. II. To estimate progression free survival in newly diagnosed patients with glioblastoma multiforme treated with R115777 before (and possibly after) radiation therapy. III. To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme. OUTLINE: This is a multicenter study. 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. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 54 patients will be accrued for this study within 11-14 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (tipifarnib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tipifarnib
Other Intervention Name(s)
R115777, Zarnestra
Intervention Description
Given orally
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Primary Outcome Measure Information:
Title
Overall survival
Description
95% confidence intervals will be estimated.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Response rate
Description
Estimated with 95% confidence intervals.
Time Frame
Up to 5 years
Title
Progression free survival
Description
Estimated with 95% confidence intervals.
Time Frame
Up to 5 years
Title
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v4.0
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lustig
Organizational Affiliation
New Approaches to Brain Tumor Therapy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Approaches to Brain Tumor Therapy Consortium
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States

12. IPD Sharing Statement

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

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