A Phase II Study of Irinotecan HCI in Patients With Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
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
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 provided as necessary:
- Antiemetic Therapy
- Loperamide (Imodium®)
- Growth Factors
- Other Concomitant Medications
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of Participants With Objective Response After 3 Cycles of Treatment
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.
3 cycles (21 day cycles)
Edward Pan, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center & Research Institute||Tampa, Florida 33612|