A Phase 1 interventional study of nelfinavir mesylate and temozolomide in Brain and Central Nervous System Tumors, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
1,919 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.
This study's enrollment of 15 is below the median of 36 across 1,617 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma multiforme)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent use of any of the following drugs:
NFV-RT-Tem
Drug: nelfinavir mesylate · Drug: temozolomide · 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
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Abramson Cancer Center at Penn Medicine