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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

Brief Summary:

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.


Detailed Summary:

Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11) in patients with recurrent anaplastic astrocytomas (AA), mixed malignant glioma, and oligodendrogliomas (OA). Patients were to be stratified by tumor histology and treated with CPT-11 every 21 days (treatment cycle).

Baseline data (collected <14 days) was to consist of a neurological/oncological history, neurological examination, height, weight, performance status, Quality Of Life FACT-L questionnaire, laboratory studies to include complete blood count (CBC), differential, platelets, prothrombin time (PT), complete metabolic panel (CMP), Lactose dehydrogenase (LDH), and a pregnancy test, as well as a cranial Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) with and without contrast (to measure or evaluate the size and location of the tumor before treatment).

Administered every 21 days was a dose of irinotecan (CPT-11), zofran/Kytril/Anzemet, decadron, and intravenous (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.

Between days 15-21 (within 7 days of next scheduled CPT-11 treatment) the following tests were to be repeated - a neurological/oncological history and neurological examination, weight, blood drawn (CMP, LDH), performance status, and Quality Of Life FACT-L questionnaire. Also, a MRI (Cranial CT/MRI with and without contrast) was to be performed for tumor assessments at week 9, 18, 27, 36, and after every nine weeks thereafter until progression. Response was to be measured by a reduction in tumor size.

These supportive therapies were provi
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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

The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.


Original Primary Outcome: Objective response rate evaluation of irinotecan

Current Secondary Outcome:

  • Overall Survival at 6 Months [ Time Frame: 6 months post treatment end ]
    Patients surviving 6 months after treatment end
  • Progression Free Survival [ Time Frame: 1 year post treatment end ]
    Patients surviving at one year post treatment end
  • Frequency and Severity of Toxicity [ Time Frame: 3 months ]
    Toxicities assessed through 3 months
  • Overall Survival at 12 Months [ Time Frame: 12 months post treatment end ]
    Patients surviving 12 months after last dose of drug


Original Secondary Outcome:

  • Overall survival and at 6 & 12 months
  • Progression Free Survival
  • Toxicity


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: August 3, 2006
Date Started: February 2006
Date Completion:
Last Updated: February 20, 2017
Last Verified: November 2011