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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003621
First received: November 1, 1999
Last updated: July 12, 2016
Last verified: July 2016
  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 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 anaplastic astrocytoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Drug: cisplatin
Drug: etoposide
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 3 Astrocytoma (Anaplastic Astrocytoma)

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: February 1999
Study Completion Date: July 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carmustine + etoposide + cisplatin + radiation therapy
Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter.
Drug: carmustine Drug: cisplatin Drug: etoposide Radiation: radiation therapy

Detailed Description:

OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic effects associated with this regimen in these patients. III. Evaluate this regimen in terms of fatigue, depression, excessive daytime somnolence, and quality of life in these patients.

OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21 and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 3 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, anaplastic astrocytoma No oligodendrogliomas or oligoastrocytomas

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/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 Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No concurrent malignant disease or major medical problem except superficial skin cancers

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 5 years since prior chemotherapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 5 years since prior radiotherapy Surgery: Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003621

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, North Dakota
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States, 58501
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Jan C. Buckner, MD Mayo Clinic
  More Information

Publications:
Jaeckle K, Ballman K, O'Fallon J, et al.: Response to pre-radiation chemotherapy as a predictor of survival in patients with newly diagnosed malignant astrocytoma: a North Central Cancer Treatment Group (NCCTG) study. [Abstract] Neuro-Oncology 6 (4): TA-26, 376, 2004.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003621     History of Changes
Other Study ID Numbers: NCCTG-987251  CDR0000066700 
Study First Received: November 1, 1999
Last Updated: July 12, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adult anaplastic astrocytoma

Additional relevant MeSH terms:
Astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Cisplatin
Etoposide
Carmustine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 30, 2016