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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003996
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Alliance for Clinical Trials in Oncology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Timothy J. Moynihan, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

Experimental: chemotherapy + carmustine + etoposide + cisplatin + radiation

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.

Interventions

Drug: - carmustine

Drug: - chemotherapy

Drug: - cisplatin

Drug: - etoposide

Radiation: - radiation therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona

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Address

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404

Peoria, Illinois

Status

Address

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602

CCOP - Carle Cancer Center, Urbana, Illinois

Status

Address

CCOP - Carle Cancer Center

Urbana, Illinois, 61801

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa

Status

Address

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206

Des Moines, Iowa

Status

Address

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016

Siouxland Hematology-Oncology, Sioux City, Iowa

Status

Address

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733

CCOP - Wichita, Wichita, Kansas

Status

Address

CCOP - Wichita

Wichita, Kansas, 67214-3882

CCOP - Ochsner, New Orleans, Louisiana

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CCOP - Ochsner

New Orleans, Louisiana, 70121

CCOP - Duluth, Duluth, Minnesota

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CCOP - Duluth

Duluth, Minnesota, 55805

Mayo Clinic Cancer Center, Rochester, Minnesota

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Address

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905

CentraCare Clinic, Saint Cloud, Minnesota

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Address

CentraCare Clinic

Saint Cloud, Minnesota, 56303

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota

Status

Address

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska

Status

Address

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131

Quain & Ramstad Clinic, P.C., Bismarck, North Dakota

Status

Address

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, 58501

Altru Health Systems, Grand Forks, North Dakota

Status

Address

Altru Health Systems

Grand Forks, North Dakota, 58201

Toledo, Ohio

Status

Address

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456

Danville, Pennsylvania

Status

Address

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, 17822-2001

Rapid City Regional Hospital, Rapid City, South Dakota

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Address

Rapid City Regional Hospital

Rapid City, South Dakota, 57709

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota

Status

Address

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57105-1080

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