Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck
Condition: Carcinoma, Adenoid Cystic; Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms; Carcinoma, Adenoid Cystic
Intervention: Nelfinavir
Intervention description: 1250 mg Nelfinavir twice daily Monday - Sunday
Intervention MeSH terms: Nelfinavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nelfinavir

Summary:

      The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an
      oncologic agent for adenoid cystic cancers of the head and neck.

      Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their
      medical oncologist as clinically indicated while taking this medication.

      Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page
      questionnaire.

      Subjects would also be evaluated clinically by the oncologist to determine if the NFV was
      having an anti-neoplastic effect.

      The study remains unfunded. Therefore, potential subjects must be willing to provide
      self-travel to study site. This study requires a screening visit, initial study visit, and
      monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of adenoid cystic carcinoma.

          -  Cancer should be staged recurrent or end-stage with/without metastases who have failed
             all other therapy.

          -  Age ≥ 18 years

          -  ECOG performance status 0-2 (Karnofsky ≥ 50%, see Appendix A).

          -  Patients must have normal organ and marrow function as defined below:

               -  leukocytes ≥ 3,000/mm3

               -  absolute neutrophil count ≥ 1,500/mm3

               -  platelets ≥ 100,000/mm3

               -  total bilirubin < 1.5 mg/dl OR a stable or a decreasing bilirubin in patients who
                  have undergone placement of an intrabiliary stent

               -  AST(SGOT) ≤ 2.5 X institutional upper limit of normal

               -  ALT(SGPT) ≤ 2.5 X institutional upper limit of normal

               -  creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥
                  60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

          -  No known HIV infection. Since NFV is used in HIV patients, we do not want to interfere
             with the therapy the patient may already be on.

          -  Not pregnant. The effects of NFV on the developing human fetus have been studied in
             HIV positive women (21). 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.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to NFV.

          -  Uncontrolled diabetes.

          -  Hemophilia A & B as increased bleeding during protease inhibitor therapy has been
             reported (22).

          -  Patients may not be receiving any other investigational agents. concomitant
             medications counterindicated for use with nelfinavir

          -  Pregnant or lactating women: The effects of NFV on the developing human fetus have
             been studied in HIV positive women (21). In addition, the chemotherapy will be
             deleterious to the fetus.

          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of
             the potential for pharmacokinetic interactions with NFV.