CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

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.

Key facts

Study ID

NCT00016328

Run by

National Cancer Institute (NCI)

People needed

33

Starts

2001-05-01

Last updated by the study team

2013-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.