Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT00915694|
Recruitment Status : Terminated (Insufficient accrual)
First Posted : June 8, 2009
Last Update Posted : April 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: nelfinavir mesylate Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma|
|Actual Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2015|
Experimental: Single arm
Drug: nelfinavir mesylate
Procedure: adjuvant therapy
Radiation: radiation therapy
- Maximum tolerated dose of nelfinavir mesylate [ Time Frame: 90 days ]
- Dose-limiting toxicities as assessed by NCI CTC v3.0 [ Time Frame: 90 days ]
- Progression-free survival [ Time Frame: One year ]
- Overall survival [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915694
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Principal Investigator:||Jay F. Dorsey, MD, PhD||Abramson Cancer Center of the University of Pennsylvania|