Irinotecan in Treating Patients With Recurrent Glioma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00003134
Phase
PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma.

Key Dates

Start date
Jan 31, 1998
Status verified
Dec 2016
Primary completion
Oct 31, 2001
Completion
Jan 31, 2009

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: irinotecan
    Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients who received prior nitrosoureas, also receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.
  • Experimental: Arm II: irinotecan
    Patients receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients who received prior nitrosoureas receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.

Primary Outcome Measure

Overall survival [ Time Frame: Up to 10 years ]

Locations (19)

FacilityCityStateZIPSite coordinators
CCOP - Scottsdale Oncology ProgramScottsdaleArizona85259-5404-
CCOP - Illinois Oncology Research AssociationPeoriaIllinois61602-
CCOP - Carle Cancer CenterUrbanaIllinois61801-
CCOP - Cedar Rapids Oncology ProjectCedar RapidsIowa52403-1206-
CCOP - Iowa Oncology Research AssociationDes MoinesIowa10309-1016-
Siouxland Hematology-OncologySioux CityIowa51101-1733-
CCOP - WichitaWichitaKansas67214-3882-
CCOP - OchsnerNew OrleansLouisiana70121-
CCOP - Ann Arbor RegionalAnn ArborMichigan48106-
CCOP - DuluthDuluthMinnesota55805-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
CentraCare ClinicSaint CloudMinnesota56303-
CCOP - Missouri Valley Cancer ConsortiumOmahaNebraska68131-
Quain & Ramstad Clinic, P.C.BismarckNorth Dakota58501-
CCOP - Merit Care HospitalFargoNorth Dakota58122-
Altru Health SystemsGrand ForksNorth Dakota58201-
CCOP - Toledo Community Hospital Oncology ProgramToledoOhio43623-3456-
CCOP - Geisinger Clinical and Medical CenterDanvillePennsylvania17822-2001-
CCOP - Sioux Community Cancer ConsortiumSioux FallsSouth Dakota57105-1080-

Find similar trials in Scottsdale, AZ

By research site
CCOP - Scottsdale Oncology Program· Scottsdale, AZCCOP - Illinois Oncology Research Association· Peoria, ILCCOP - Carle Cancer Center· Urbana, ILCCOP - Cedar Rapids Oncology Project· Cedar Rapids, IACCOP - Iowa Oncology Research Association· Des Moines, IASiouxland Hematology-Oncology· Sioux City, IA

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