Irinotecan in Treating Patients With Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003301
First received: November 1, 1999
Last updated: June 20, 2013
Last verified: September 2005
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients with recurrent malignant glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: irinotecan hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Dose Finding and Safety/Efficacy Trial of CPT-11 (Irinotecan) in Patients With Recurrent Malignant Gliomas

Resource links provided by NLM:


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

Study Start Date: July 1998
Study Completion Date: April 2004
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of intravenous irinotecan when administered weekly for 4 weeks in patients with recurrent malignant gliomas. II. Describe the pharmacokinetics of this route of administration, measuring both irinotecan and the active metabolite SN-38, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics in these patients. III. Determine preliminary response data and activity of irinotecan in this patient population. IV. Correlate response with topoisomerase I levels in brain tumor tissue from patients undergoing treatment.

OUTLINE: Patients are stratified based on their use/kind of anticonvulsant drugs. This stratification yields two arms for this study. Arm I consists of patients who use anticonvulsant drugs that induce hepatic metabolic enzymes. Arm II consists of patients who use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or no anticonvulsant drug. Three patients in each arm receive irinotecan by 90-minute IV infusions every week for 4 weeks, followed by a 2 week rest period. The dose is escalated for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity. The 6 week course is repeated until unacceptable toxicity or disease progression. Once the maximum tolerated dose has been established for each arm, additional patients are treated at that dose level. Patients are followed every 2 months.

PROJECTED ACCRUAL: A minimum of 3 patients will be accrued into the phase I portion of the study and a total of 18-35 patients will be accrued into each arm of the phase II portion of the study.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma that is progressive or recurrent following radiation therapy or chemotherapy Anaplastic astrocytoma Glioblastoma multiforme Low grade glioma that has progressed to biopsy proven high grade glioma is eligible if the progression occurred after radiotherapy with or without chemotherapy Measurable progression or recurrence by serial MR or CT imaging

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 2 months Hematopoietic: Absolute neutrophil count 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No uncontrolled hypertension No angina pectoris No evidence of uncontrolled cardiac dysrhythmia Other: No serious infection or other medical illness No other prior or concurrent malignancy within 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior topoisomerase 1 inhibitor (topotecan, irinotecan, 9- aminocamptothecin) No more that 1 prior chemotherapy regimen At least 6 weeks since nitrosourea and recovered At least 3 weeks since any other chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 months since completion of most recent course of radiotherapy and recovered Surgery: Not specified Other: No concurrent investigational agents At least 14 days since prior valproic acid No concurrent valproic acid

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003301

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
New Approaches to Brain Tumor Therapy
Investigators
Study Chair: Tracy Batchelor, MD, MPH Massachusetts General Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003301     History of Changes
Other Study ID Numbers: CDR0000066241, NABTT-9711, JHOC-NABTT-9711
Study First Received: November 1, 1999
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014