Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00360828
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan Hydrochloride (HCI) Treatment — DRUG
    Irinotecan injections. Irinotecan hydrochloride \[CPT-11; CAMPTOSAR\] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.
  • Continued Irinotecan Hydrochloride (HCI) Treatment — DRUG
    For patients responding to treatment, therapy could have continued beyond 18 cycles.

Study Details

Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.

Key Dates

Start date
Feb 28, 2006
Status verified
Nov 2011
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Irinotecan Treatment
    Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.

Primary Outcome Measure

Number of Participants With Objective Response After 3 Cycles of Treatment [ Time Frame: 3 cycles (21 day cycles) ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
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By specialty
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By research site
H. Lee Moffitt Cancer Center & Research Institute· Tampa, FL

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