Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir mesylate when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme.

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

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Nelfinavir; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma multiforme)

• Newly diagnosed disease

• Has undergone maximal surgical resection

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Serum creatinine < 1.5 times upper limit of normal (ULN)

• AST or ALT < 2 times ULN

• Serum bilirubin < 1.5 mg/dL

• No known HIV infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior cranial radiotherapy

• More than 30 days since prior investigational agents

• No other concurrent investigational agents

• No concurrent use of any of the following drugs:

• Antiarrhythmics (i.e., amiodarone or quinidine)

• Antimycobacterials (i.e., rifampin)

• Ergot derivatives (i.e., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)

• Herbal products (i.e., St. John's wort)

• HMG-CoA reductase inhibitors (i.e., lovastatin or simvastatin)

• Neuroleptics (i.e., pimozide)

• Sedatives and/or hypnotics (i.e., midazolam or triazolam)

• Concurrent corticosteroids allowed provided dose has been stable or decreasing for ≥ 14 days prior to study entry