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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Kentuckiana Cancer Institute
Study ID
NCT00283556
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan (Camptosar, CPT-11) — DRUG
    Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2001
Status verified
Jan 2010
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort #1
    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.
  • Experimental: Cohort #2
    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.
  • Experimental: Cohort #3
    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.

Primary Outcome Measure

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. [ Time Frame: 2008 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kentuckiana Cancer InstituteLouisvilleKentucky40202-

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By research site
Kentuckiana Cancer Institute· Louisville, KY

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