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Irinotecan in Treating Patients With Recurrent Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult brain stem glioma, adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology
  • CCOP - Wichita
  • CCOP - Ochsner
  • CCOP - Ann Arbor Regional
  • CCOP - Duluth
  • Mayo Clinic Cancer Center
  • CentraCare Clinic
  • CCOP - Missouri Valley Cancer Consortium
  • Quain & Ramstad Clinic, P.C.
  • CCOP - Merit Care Hospital
  • Altru Health Systems
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Geisinger Clinical and Medical Center
  • CCOP - Sioux Community Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I: irinotecan

Arm II: irinotecan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 5, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003134
Brief Title
Irinotecan in Treating Patients With Recurrent Glioma
Official Title
A Phase II Trial of Irinotecan in Recurrent Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult brain stem glioma, adult oligodendroglioma, adult mixed glioma, adult diffuse astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: irinotecan
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II: irinotecan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan C. Buckner, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
10309-1016
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CentraCare Clinic
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Quain & Ramstad Clinic, P.C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Health Systems
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Geisinger Clinical and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19066728
Citation
Santisteban M, Buckner JC, Reid JM, Wu W, Scheithauer BW, Ames MM, Felten SJ, Nikcevich DA, Wiesenfeld M, Jaeckle KA, Galanis E; North Central Cancer Treatment Group. Phase II trial of two different irinotecan schedules with pharmacokinetic analysis in patients with recurrent glioma: North Central Cancer Treatment Group results. J Neurooncol. 2009 Apr;92(2):165-75. doi: 10.1007/s11060-008-9749-4. Epub 2008 Dec 10.
Results Reference
result
PubMed Identifier
16863926
Citation
Laack NN, Ballman KV, Brown PB, O'Neill BP; North Central Cancer Treatment Group. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group (NCCTG) 96-73-51. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1429-39. doi: 10.1016/j.ijrobp.2006.03.061.
Results Reference
result

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Irinotecan in Treating Patients With Recurrent Glioma

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