High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma

Kentuckiana Cancer Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Malignant Glioma

Treatments: Drug: Irinotecan (Camptosar, CPT-11)

Study type: Interventional

Funder types: Other

Identifiers

NCT00283556

1068114

44OE-ONC-0020-3

Details and patient eligibility

About

The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Full description

This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• recurrent, unresectable primary CNS neoplasm per MRI
• ECOG status of 2 or less
• no prior therapy with camptothecans
• on an enzyme-inducing antiepileptic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Cohort #1

Experimental group

Description:

Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes every (Q) 3 weeks x 15 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.

Treatment:

Drug: Irinotecan (Camptosar, CPT-11)

Cohort #2

Experimental group

Description:

Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.

Treatment:

Drug: Irinotecan (Camptosar, CPT-11)

Cohort #3

Experimental group

Description:

Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.

Treatment:

Drug: Irinotecan (Camptosar, CPT-11)