CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence

• Gliosarcoma allowed

• Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line chemotherapy

• Measurable or evaluable disease by MRI or CT scan

• Performance status - ECOG 0-2

• Absolute neutrophil count at least 1,500/mm^3

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

• Hemoglobin at least 9 g/dL

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 3 times upper limit of normal

• Creatinine no greater than 2.0 mg/dL

• No myocardial infarction within the past 6 months

• No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias

• Cholesterol no greater than 350 mg/dL

• Triglycerides no greater than 400 mg/dL

• Willing to provide correlative laboratory samples

• No uncontrolled infection

• No known hypersensitivity to any components of CCI-779, diphenhydramine hydrochloride, or other similar antihistamines

• No other medical reason that would preclude diphenhydramine premedication

• No other active malignancy

• No other severe disease that would preclude study participation

• Not immunocompromised unless due to corticosteroids

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• See Disease Characteristics

• Prior adjuvant chemotherapy allowed

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No more than 1 prior chemotherapy regimen for recurrent/progressive disease

• No prior polifeprosan 20 with carmustine implant (Gliadel)

• Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week prior to baseline scan

• See Disease Characteristics

• At least 12 weeks since prior radiotherapy

• No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is outside of the previously treated field

• No prior resection since last chemotherapy or radiotherapy unless there is unequivocal tumor growth on neuro-imaging study since surgery or there is a separate lesion not present in the surgical bed

• More than 4 weeks since prior investigational agents