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Completed

NCT Number: NCT00003996

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

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About this study

OBJECTIVES: I. Evaluate the efficacy of carmustine, cisplatin, and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. II. Assess the toxicities of this treatment regimen in this patient population. III. Assess fatigue, depression, and excessive daytime somnolence in terms of incidence, duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this patient population. IV. Evaluate the quality of life of these patients.

OUTLINE: Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme No oligodendrogliomas or oligoastrocytomas

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 130,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 0.5 mg/dL above ULN Other: No uncontrolled infection No other major medical conditions No other concurrent malignancy except superficial skin cancers Must be able to read English (quality of life assessment only) No other problem that may preclude quality of life assessment Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: No prior radiotherapy Surgery: Not specified

Treatment and study plan

carmustine

Drug

Chemotherapy

Drug

Cisplatin

Drug

etoposide

Drug

radiation therapy

Radiation

Primary outcomes

  1. overall survival

    Time frame: Up to 10 years

Secondary outcomes

  1. quality of life

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Trial of Pre-irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)

Important dates

Study start
1999
Primary completion
2001
Study completion
2008
First posted
Jun 17, 2004
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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