Status:
TERMINATED
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 c...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently with radiotherapy and temozolomide followed by temozolomide alone in patients with glioblast...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00915694
Start Date
April 1 2009
End Date
December 1 2015
Last Update
April 23 2019
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283