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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00915694
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Abramson Cancer Center at Penn Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jay F. Dorsey, MD, PhD
Principal Investigator Affiliation Abramson Cancer Center at Penn Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Single arm

NFV-RT-Tem

Interventions

Drug: - nelfinavir mesylate

Drug: - temozolomide

Procedure: - adjuvant therapy

Radiation: - radiation therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Address

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283

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