Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas
Condition: Astrocytoma; Glioma; Oligodendroglioma
MeSH terms: Glioma; Astrocytoma; Oligodendroglioma
Intervention: Irinotecan Hydrochloride (HCI) Treatment; Continued Irinotecan Hydrochloride (HCI) Treatment
Intervention description: 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.; For patients responding to treatment, therapy could have continued beyond 18 cycles.
Intervention MeSH terms: Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Anaplastic Astrocytoma; Mixed Malignant Glioma; Oligodendroglioma; Irinotecan; Brain tumor; Nitrosoureas; Brain and nervous system

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.
    

Eligibility 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.