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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

1171

NCT ID:

NCT00003464

Start Date:

September 1997

Completion Date:

August 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710