Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any remaining tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Vorinostat

Criteria

Inclusion Criteria:

• Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including gliosarcoma, at primary diagnosis or recurrence

• Progressive or recurrent disease

• Measurable or evaluable disease by MRI or CT scan

• Performance status - ECOG 0-2

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 8 g/dL

• AST ≤ 3 times upper limit of normal (ULN)

• Bilirubin normal

• Creatinine ≤ 1.5 times ULN

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy

• No known HIV positivity

• Not immunocompromised except if related to the use of corticosteroids

• No known hypersensitivity to any of the components of the study drug

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No other malignancy

• No other severe disease that would preclude study participation

• Prior adjuvant chemotherapy allowed

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

• More than 2 weeks since prior small molecule cell cycle inhibitor

• Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week

• At least 8 weeks since prior radiotherapy

• Must have evidence of tumor progression by MRI or CT scan after radiotherapy

• More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless 1 of the following criteria is met:

• There is a separate lesion by MRI outside of the prior treatment field

• There is evidence of recurrent disease by biopsy, MRI spectroscopy, or positron-emission tomography scan

• More than 2 weeks since prior valproic acid