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National Cancer Institute - U.S. National Institutes of Health - www.cancer.gov

Trial FAQs

A Phase I Trial of Nelfinavir (Viracept®) in Adults With Solid Tumors

Protocol # 07-C-0047

Why is this trial important?

This trial is important because it tests an FDA approved drug that is well tolerated and has been widely used in HIV infected persons. The drug potentially works by targeting pathways known to be activated in many tumors. If efficacy is shown in cancer patients, this agent can be directly repositioned for treatment of malignancy without the prolonged safety testing or approval process.

Who is eligible for this trial? (PDQ)

  • Histologically confirmed solid malignancy that is refractory to standard therapy
  • Adequate bone marrow, liver, and kidney function defined as neutrophil count ≥ 1500, platelet count ≥ 100,000, total bilirubin < 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN, and creatinine ≤ 1.5 x ULN
  • Women of childbearing potential must have a negative pregnancy test; patients must agree to discontinue oral contraceptives and use barrier method contraception for the duration of the study
  • Patients with brain metastasis must have undergone evaluation and appropriate counseling and treatment by radiation oncology
  • Patients with acute narrow-angle glaucoma or untreated open-angle glaucoma are ineligible
  • Patients are ineligible if they are on the following CYP3A4 inhibitors and cannot replace these medications with an equivalent agent for the period of study: amiodarone, quinidine, pimozide, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, methylergonovine, lovastatin, simvastatin, atorvastatin, rifampin, rifabutin, felodipine, nifedipine, sildenafil, or St. John's wort

What types of drugs or therapies are being used?

We are testing a drug called nelfinavir. It is an FDA approved HIV protease inhibitor currently in use for treatment of HIV infection. It is a well-tolerated oral agent taken twice a day and recent studies have shown that it has activity as a cancer agent in animal models of cancer.

What is the treatment plan? (PDQ)

This trial is a phase I dose escalation study designed to determine the maximally tolerated dose of nelfinavir, an FDA approved medication with widespread human use in human immunodeficiency virus infection.

  • Patients will be enrolled in cohorts of 3 to 6 patients, with a maximum enrollment of 45 patients
  • The first cohort of patients will receive nelfinavir 1250 mg orally twice a day, the dose that is approved for use and well-tolerated in HIV infected patients
  • The nelfinavir dose is escalated provided that less than one out of three patients in the cohort experiences dose limiting toxicity
  • The maximum tolerated dose will be the dose level at which one out of six patients experiences dose limiting toxicity
  • Pharmacokinetic studies using a midazolam probe will be performed at baseline and again at Day 20 of the first cycle
  • Each treatment cycle is 21 days
  • Restaging is performed every two cycles
  • Patients may continue on nelfinavir as long as they are not experiencing dose limiting toxicity or progression of their cancer
  • Tumor biopsies may be performed, but are not required for eligibility

What is the frequency and duration of the visits?

The first cycle requires weekly clinic visits (a total of 3 visits, each approximately 2 hours) to monitor for toxicity. Pharmacokinetic testing that requires a 5 hour stay at the clinical center will be done twice early in the study (Days -2 and 20). Pharmacokinetic testing requiring a 12 hour stay occurs early in cycle 1 and again at the beginning of cycle 2. Each cycle is 21 days in length. After the first cycle, patients are seen once every 21 days in the clinic (approximately 2 hours). This trial is planned to be executed in the outpatient setting. There are no planned admissions.

What are the costs?

There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.

It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.

No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.

Who is the Principal Investigator?

Dr. Phillip A. Dennis received his B.A. in 1984 as an Echols Scholar from the University of Virginia, and his Ph.D. and M.D. degrees in 1991 and 1992, respectively, from the New York University School of Medicine as part of the Medical Scientist Training Program. He completed his internal medicine training on the Osler Medical Service at Johns Hopkins Hospital. Following his residency, he completed a fellowship in medical oncology at the Johns Hopkins Oncology Center. Dr. Dennis joined NCI in 1999 as a tenure track investigator. In 2005, he became clinical service director at NCI/Navy Medical Oncology, and in 2006 became a senior investigator in the Medical Oncology Branch.

Where is this trial taking place?

NIH Clinical Center
National Institutes of Health
NCI Medical Oncology Branch and Affiliates
10 Center Drive
Bethesda, Maryland 20892

National Naval Medical Center
NCI Medical Oncology Branch
8901 Wisconsin Avenue
Bethesda, Maryland 20889

Who are the contacts for this trial?

Phillip A. Dennis, M.D., Ph.D.
Principal Investigator
Phone: 301-496-0929
pdennis@nih.gov

Gideon Blumenthal, M.D.
Protocol Chair
Phone: 301-435-5868
blumentg@mail.nih.gov

Referrals:

Hyejeong Root, R.N., M.S.N.
Research Nurse
Phone: 301-402-0998
Fax: 301-480-2590
roothy@mail.nih.gov

Where can additional information be found?

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