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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00915694
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 5, 2009
June 5, 2009
April 2009
April 2012   (final data collection date for primary outcome measure)
  • Maximum tolerated dose of nelfinavir mesylate [ Designated as safety issue: Yes ]
  • Dose-limiting toxicities as assessed by NCI CTC v3.0 [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

  • 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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: nelfinavir mesylate
  • Drug: temozolomide
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
31
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00915694
CDR0000644278, UPCC-01309, IRB#809463
Not Provided
Jay F. Dorsey, Abramson Cancer Center of the University of Pennsylvania
University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Jay F. Dorsey, MD, PhD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP