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A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma

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: NCT01020292
Recruitment Status : Completed
First Posted : November 24, 2009
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established. Case studies have also reported that HIV patients have received radiotherapy for cancer, while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19 additional subjects will be enrolled to generate pilot data on radiographic response and to evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.

Condition or disease Intervention/treatment Phase
Glioma Drug: Nelfinavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
Study Start Date : April 2009
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NFV and Concurrent ChemoRads Drug: Nelfinavir

Primary Outcome Measures :
  1. To determine the safety, dose-limiting toxicities, and maximally tolerated dose of NFV concurrently with radiation and temozolomide. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To determine the progression free survival (PFS) and overall survival (OS) with an exploratory analysis to compare the observed median value obtained in this study to the historical median values of 6.9 months and 14.6 months respectively. [ Time Frame: Two years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients > 18 years old.
  2. Newly diagnosed and histologically confirmed supratentorial WHO Grade IV astrocytoma status-post maximally achievable resection.
  3. ECOG performance status 0-2.
  4. Absolute Neutrophil Count ≥ 1500 per mm3
  5. Platelet count ≥ 100,000 per mm3
  6. Serum creatinine < 1.5 times the upper limit of normal
  7. Serum AST or ALT < 2 times the upper limit of normal
  8. Serum bilirubin < 1.5 mg/dl
  9. Patients who were receiving corticosteroids have to receive a stable or decreasing dose for at least 14 days before randomization.
  10. No prior cranial radiotherapy will be permitted.
  11. No known HIV infection.
  12. The effects of NFV on the developing human fetus have been studied in HIV positive women.

    We do not, however, know the risks along with radiation. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

  13. Patients must sign an informed consent document that indicates they are aware of the investigative nature of the treatment in this protocol as well as the potential risks and benefits.

Exclusion Criteria:

  1. Prior cranial radiotherapy.
  2. Patients may not be receiving or have received any other investigational agents during/or within 1 month prior to treatment with NFV.
  3. Pregnant or lactating women.
  4. Patients receiving the following drugs that are contraindicated with NFV will be excluded: antiarrhythmics (amiodarone, quinidine), antimycobacterial (rifampin), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), herbal products (St. John's wort), HMG-CoA reductase inhibitors (lovastatin, simvastatin), neuroleptic (pimozide), proton pump inhibitors, sedatives/hypnotics (midazolam, triazolam).
  5. Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: anti-convulsants (carbamazepine, phenobarbital, phenytoin), anti-mycobacterial (rifabutin), PDE5 inhibitors (sildenafil, vardenafil, tadalafil), HMG-CoA reductase inhibitor (atorvastatin, rosuvastatin), immunosuppressants (cyclosporine, tacrolimus, sirolimus), narcotic analgesic (methadone), oral contraceptive (ethinyl estradiol), macrolide antibiotic (azithromycin), antidepressant (trazadone).

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): NCT01020292

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01020292    
Other Study ID Numbers: UPCC 01309
First Posted: November 24, 2009    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adult subjects with a diagnosis of Grade IV Glioma
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents