Clinical trial · Interventional
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
A Phase I Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| nelfinavir mesylate | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- NFV-RT-Tem
- interventionNames
- Drug: nelfinavir mesylate
- Drug: temozolomide
- Procedure: adjuvant therapy
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Maximum tolerated dose of nelfinavir mesylate
- timeFrame
- 90 days
- measure
- Dose-limiting toxicities as assessed by NCI CTC v3.0
- timeFrame
- 90 days
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available