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Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00915694
Recruitment Status : Terminated (Insufficient accrual)
First Posted : June 8, 2009
Last Update Posted : April 23, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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 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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Single arm
Drug: nelfinavir mesylate
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy

Primary Outcome Measures :
  1. Maximum tolerated dose of nelfinavir mesylate [ Time Frame: 90 days ]
  2. Dose-limiting toxicities as assessed by NCI CTC v3.0 [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: One year ]
  2. Overall survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed WHO grade IV supratentorial astrocytoma (glioblastoma multiforme)

    • Newly diagnosed disease
  • Has undergone maximal surgical resection


  • 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


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00915694

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
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Principal Investigator: Jay F. Dorsey, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Additional Information:
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00915694    
Other Study ID Numbers: CDR0000644278
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
adult giant cell glioblastoma
adult gliosarcoma
adult glioblastoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents