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

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Patients must have histological or neuroradiographic documented recurrent glioma defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All patients must have had prior pathologic confirmation of primary tumor histology.

• Patients must be > than or equal to 18 years old.

• Patients must have a Karnofsky performance score (KPS) of > or equal to 50

• Measurable disease per MacDonald criteria is required

• Patients must have a predicted life expectancy of at least 12 weeks

• Required initial laboratory data:

1. Absolute Neutrophil Count (ANC) > 1,500

2. Platelets > 100,000

3. Serum Creatinine < 2.0

4. Serum Bilirubin < 2.0

5. Aspartamine transaminase/ Alanine transaminase (AST/ALT) < 3x normal

6. Pregnancy test for females with child-bearing potential negative

• Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).

• Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.

• Patients must have been previously treated with both surgery and radiotherapy.

• Prior adjuvant and one salvage chemotherapy regimen is permitted.

• Prior stereotactic radiotherapy is permitted.

Exclusion Criteria:

• Patients have evidence of leptomeningeal spread of disease.

• Patients having been treated with 2 or more salvage regimens.

• Pregnant or breast-feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use adequate contraceptives may not participate.

• Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic diarrhea or presence of a bowel obstruction.

• Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.

• Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.

• Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.

• Known to be human immunodeficiency virus (HIV) positive or to have an acquired immunodeficiency syndrome (AIDS) related illness.

• Patients with an active infection that is not adequately controlled with antibiotics.

• Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

• Patients with a known sensitivity to any of the products to be administered during treatment.

• Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.

• Patients previously treated with CPT-11.

• Concurrent stereotactic radiotherapy.