Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003464
• Other study ID #: 1171
• Secondary ID: DUMC-1171-01-6R4
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 19, 2013
• Start date: September 1997
• Est. completion date: August 2003

Study information

• Verified date: October 2009
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• temozolomide

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,