CCI-779 in Treating Patients With Malignant Glioma

• Status: Completed
• Trial end date: 2007-12-15
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intracranial malignant glioma

• Glioblastoma multiforme

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Malignant astrocytoma not otherwise specified

• Initial diagnosis of low-grade allowed, if subsequently progressed

• Recurrent disease must have documented progression by MRI or CT scan

• Progressive disease must have failed prior radiotherapy

• Recent resection of recurrent or progressive tumor allowed provided all of the following are met:

• Recovered from surgery

• CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively

• Concurrent steroid dosage must be stable

• Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 8 weeks

Hematopoietic:

• WBC at least 3,000/mm3

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 120,000/mm3

• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT less than 1.5 times ULN

• Cholesterol less than 350 mg/dL

• Triglycerides less than 400 mg/dL

Renal:

• Creatinine less than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

Other:

• No active infection

• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No significant medical illness that would preclude study

• No disease that would obscure toxicity or dangerously alter drug metabolism

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 12 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 1 week since prior interferon

Chemotherapy:

• At least 2 weeks since prior vincristine

• At least 3 weeks since prior procarbazine

• At least 6 weeks since prior nitrosoureas

• Phase I:

• 2 prior chemotherapy regimens allowed

• 1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR

• 2 prior regimens for progressive tumor

• Phase II:

• No more than 1 prior chemotherapy regimen for recurrent malignant glioma

• No prior chemotherapy allowed for stable glioblastoma multiforme

Endocrine therapy:

• See Disease Characteristics

• At least 1 week since prior tamoxifen

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy for progressive disease

• No more than 1 month since prior radiotherapy for nonprogressive glioblastoma multiforme

Surgery:

• See Disease Characteristics

Other:

• Recovered from prior therapy

• At least 1 week since prior noncytotoxic agents