Glioma Clinical Trial
Official title:
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). 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.
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 provided as necessary:
- Antiemetic Therapy
- Anticholinergics
- 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
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