search
Back to results

Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
radiation therapy
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy At least 1 bidimensionally measurable lesion PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring intravenous antibiotics No frequent vomiting No other medical condition that would interfere with oral medication intake such as partial bowel obstruction No prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell carcinoma of the skin HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: No prior radiation therapy No prior interstitial brachytherapy No prior radiosurgery to the brain Not requiring immediate radiation therapy No concurrent radiotherapy Surgery: Recovered from any effects of prior surgery At least 2 weeks since prior surgical resection Other: No other concurrent investigational drugs

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 19, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003464
Brief Title
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
Official Title
Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.
Detailed Description
OBJECTIVES: Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme. Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients. Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide. OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: This study will accrue 50 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed, supratentorial malignant glioblastoma multiforme not requiring immediate radiation therapy At least 1 bidimensionally measurable lesion PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: BUN less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Must be neurologically stable No systemic disease No acute infection requiring intravenous antibiotics No frequent vomiting No other medical condition that would interfere with oral medication intake such as partial bowel obstruction No prior or concurrent malignancies except: Surgically cured carcinoma in situ of the cervix Basal or squamous cell carcinoma of the skin HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy No concurrent biologic therapy (growth factors or erythropoietin) Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent steroid allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: No prior radiation therapy No prior interstitial brachytherapy No prior radiosurgery to the brain Not requiring immediate radiation therapy No concurrent radiotherapy Surgery: Recovered from any effects of prior surgery At least 2 weeks since prior surgical resection Other: No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Friedman, MD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

We'll reach out to this number within 24 hrs