View Clinical Trial (Medical Research Study)
A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- Determine the maximum tolerated dose of nelfinavir mesylate when given concurrently
with radiotherapy and temozolomide followed by temozolomide alone in patients with
glioblastoma multiforme.
- Determine the safety and dose-limiting toxicities of this regimen in these patients.
Secondary
- Determine the progression-free survival (PFS) and overall survival (OS) of patients
treated with this regimen.
- Compare the observed median values of PFS and OS obtained in this study to the
historical median values of 6.9 months and 14.6 months, respectively.
OUTLINE: This is a dose-escalation study of nelfinavir mesylate.
Patients receive oral nelfinavir mesylate twice daily beginning 7-10 days before the
initiation of chemoradiotherapy and continuing until the completion of chemoradiotherapy.
Patients undergo radiotherapy once daily 5 days a week and receive concurrent oral
temozolomide once daily for 6 weeks. Beginning 4 weeks after completion of nelfinavir
mesylate and chemoradiotherapy, patients receive oral temozolomide alone once daily on days
1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
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| Criteria: |
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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
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| NCT ID: |
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NCT00915694 |
| Primary Contact: |
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Principal Investigator
Jay F. Dorsey, MD, PhD
Abramson Cancer Center of the University of Pennsylvania
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Clinical Trials Office - Abramson Cancer Center of the Univers
Phone: 800-474-9892
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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