Sirolimus in Treating Patients With Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemotherapy drugs such as sirolimus use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase I/II trial to study the effectiveness of sirolimus in treating patients who have glioblastoma multiforme that did not respond to previous radiation therapy.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed intracranial glioblastoma multiforme

• Disease progression by MRI or CT scan

• Confirmation of true progressive disease (not radiation necrosis) by positron-emission tomography, thallium scanning, MRI, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery

• Failed prior radiotherapy

• Phase I patients:

• Eligible for salvage surgery

• No limits on prior therapy

• Phase II patients:

• Tumor progression by MRI or CT scan required within the past 14 days if recurrent disease is present

• No prior therapy for more than 3 relapses

• Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply:

• Recovered from surgery

• MRI or CT scan performed no more than 96 hours since prior surgery OR within 4-6 weeks after surgery

• Baseline MRI or CT scan performed within 14 days of study entry

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

• 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

Renal

• Creatinine less than 1.5 mg/dL

Other

• Cholesterol less than 350 mg/dL

• Triglycerides less than 400 mg/dL

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

• No other significant uncontrolled serious medical illness that would preclude study participation

• No other cancer except non-melanoma skin cancer or carcinoma in situ of the cervix unless patient is in complete remission and off all therapy for that disease for at least 3 years

• No active infection

• No prior allergic reactions to compounds of similar chemical or biological composition to sirolimus

• No psychiatric illness that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

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

Endocrine therapy

• At least 1 week since prior tamoxifen

Radiotherapy

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• Recovered from prior therapy

• At least 1 week since prior noncytotoxic agents (except radiosensitizers)