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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2013
• Main ID: NCT01020292
• Date of registration: 23/11/2009
• Primary sponsor: Abramson Cancer Center of the University of Pennsylvania
• Public title: A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
• Scientific title: Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
• Date of first enrolment: April 2009
• Target sample size: 31
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01020292
• Study type: Interventional
• Study design: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Glioma

Intervention(s)

Drug: Nelfinavir

Primary Outcome(s)

To determine the safety, dose-limiting toxicities, and maximally tolerated dose of NFV concurrently with radiation and temozolomide. [Time Frame: Yes]

Secondary Outcome(s)

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: Yes]

Secondary ID(s)

UPCC 01309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors