MedPath

Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Interventions
Registration Number
NCT00002806
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and vincristine followed by radiation therapy in treating adults who have supratentorial glioma.

Detailed Description

OBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial low-grade glioma following neoadjuvant chemotherapy with PCV (procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the incidence of disease progression in these patients during PCV treatment.

OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine, NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least 6 MV photons.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
procarbazine + lomustine + vincristine + radiationlow-LET photon therapyPCV followed by external-beam cranial irradiation using at least 6 MV photons.
procarbazine + lomustine + vincristine + radiationvincristine sulfatePCV followed by external-beam cranial irradiation using at least 6 MV photons.
procarbazine + lomustine + vincristine + radiationprocarbazine hydrochloridePCV followed by external-beam cranial irradiation using at least 6 MV photons.
procarbazine + lomustine + vincristine + radiationlomustinePCV followed by external-beam cranial irradiation using at least 6 MV photons.
Primary Outcome Measures
NameTimeMethod
Response rateUp to 5 years
Secondary Outcome Measures
NameTimeMethod
Disease progressionUp to 5 years

Trial Locations

Locations (17)

CCOP - Toledo Community Hospital Oncology Program

🇺🇸

Toledo, Ohio, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

Siouxland Hematology-Oncology

🇺🇸

Sioux City, Iowa, United States

CCOP - Geisinger Clinical and Medical Center

🇺🇸

Danville, Pennsylvania, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

CCOP - Merit Care Hospital

🇺🇸

Fargo, North Dakota, United States

Quain & Ramstad Clinic, P.C.

🇺🇸

Bismarck, North Dakota, United States

Altru Health Systems

🇺🇸

Grand Forks, North Dakota, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

🇺🇸

Cedar Rapids, Iowa, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

CCOP - Iowa Oncology Research Association

🇺🇸

Des Moines, Iowa, United States

Rapid City Regional Hospital

🇺🇸

Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium

🇺🇸

Sioux Falls, South Dakota, United States

CCOP - Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

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