Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00003616
• Date of registration: 01/11/1999
• Primary sponsor: North American Brain Tumor Consortium
• Public title: Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
• Scientific title: Phase I/II Trial of Irinotecan (CPT-11) in Patients With Recurrent Malignant Glioma
• Date of first enrolment: September 1998
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00003616
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael Prados, MD
• Affiliation: UCSF Medical Center at Parnassus

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Histologically proven progressive or recurrent primary malignant
glioma Phase I (excluding group A patients): No more than 2 prior chemotherapy regimens,
including 1 prior adjuvant therapy and 1 prior regimen for recurrent or progressive tumor,
or 2 prior regimens for progressive tumor Phase II and/or group A patients: No more than 1
prior chemotherapy regimen, either as adjuvant or for recurrent disease Measurable disease
by MRI or CT scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater
than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL
Cardiovascular: No uncontrolled hypertension No unstable angina No symptomatic congestive
heart failure No myocardial infarction within 6 months No serious uncontrolled cardiac
arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception No severe nonmalignant systemic disease or active infection No
concurrent alcoholism or drug abuse No psychosis HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy No concurrent
sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics At least 4 weeks since
prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or suramin) No prior irinotecan,
topotecan, or other topotecan 1 inhibitors No other concurrent chemotherapy Endocrine
therapy: Stable or decreasing dosage of corticosteroids within 72 hours of study entry
(phase II only) No other concurrent immunosuppressive agents No concurrent hormonal
therapy Radiotherapy: At least 4 weeks since prior radiotherapy Patients with prior
interstitial brachytherapy or stereotactic radiosurgery must have confirmation of
progressive disease No concurrent radiotherapy Surgery: At least 3 weeks since prior
resection Other: Acute toxic effects (excluding neurotoxicity or alopecia) of any prior
therapy must be resolved No concurrent valproic acid as a single agent Concurrent
enzyme-inducing antiepileptic drugs (EIAED) with or without steroids are allowed No
concurrent investigational drugs



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Brain and Central Nervous System Tumors

Intervention(s)

Drug: irinotecan hydrochloride

Secondary ID(s)

CDR0000066694

NABTC-9801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)