ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Irinotecan in Treating Patients With Recurrent Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003134
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Irinotecan in Recurrent Glioma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   60
Study Start Date:   January 1998

Detailed Description:

OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate the pharmacological parameters with toxicity and response to therapy.

OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any time. Patients assigned to arm I 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 assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients in both arms 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. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 30 patients in each treatment arm in 24 months, for a total of 60 patients.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven primary brain glioma Astrocytoma Gliosarcoma Oligodendroglioma Oligoastrocytoma Tumor progression by CT scan or MRI following radiotherapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal No prior Gilbert's syndrome Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of myocardial infarction within 6 months No congestive heart failure requiring therapy Other: No concurrent active second malignancy No uncontrolled infection No other severe concurrent disease Not pregnant or lactating Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior adjuvant chemotherapy regimen and 1 for recurrence (Gliadel is considered 1 regimen) At least 4 weeks since prior chemotherapy At least 6 weeks since prior nitrosoureas No prior irinotecan, topotecan, or aminocamptothecin Endocrine therapy: At least 2 weeks on fixed dose of corticosteroids (or no corticosteroids) prior to baseline scan Radiotherapy: At least 8 weeks since prior radiotherapy Surgery: No surgical resection between last radiotherapy or chemotherapy and study therapy, unless unequivocal tumor growth since surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003134

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program    
      Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Carle Cancer Center    
      Urbana, Illinois, United States, 61801
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, 10309-1016
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, Michigan
CCOP - Ann Arbor Regional    
      Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth    
      Duluth, Minnesota, United States, 55805
CentraCare Clinic    
      Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center    
      Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium    
      Omaha, Nebraska, United States, 68131
United States, North Dakota
Altru Health Systems    
      Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital    
      Fargo, North Dakota, United States, 58122
Quain & Ramstad Clinic, P.C.    
      Bismarck, North Dakota, United States, 58501
United States, Ohio
CCOP - Toledo Community Hospital Oncology Program    
      Toledo, Ohio, United States, 43623-3456
United States, Pennsylvania
CCOP - Geisinger Clinical and Medical Center    
      Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
CCOP - Sioux Community Cancer Consortium    
      Sioux Falls, South Dakota, United States, 57105-1080

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Jan C. Buckner, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Laack N, Ballman KV, Brown PB, et al.: Whole-brain radiotherapy (WBRT) and high-dose methylprednisolone (HDMP) for elderly patients with primary central nervous system lymphoma (PCNSL): results of North Central Cancer Treatment Group (NCCTG) 96-72-51. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-1007, S260, 2004.
 

Study ID Numbers:   CDR0000065900, NCCTG-967251
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003134
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
adult brain stem glioma  
adult oligodendroglioma  
mixed gliomas  
adult diffuse astrocytoma  

Study placed in the following topic categories:
Astrocytoma
Irinotecan
Central Nervous System Neoplasms
Recurrence
Camptothecin
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers