Stereotactic Body Radiation With Nelfinavir for Oligometastases
Condition: Oligometastases
Intervention: Nelfinavir; Stereotactic Body Radiation (SBRT)
Intervention description: Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.; 15 Gy dose (per lesion site) of SBRT will be administered
Intervention MeSH terms: Nelfinavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with metastatic lesions of the lung, liver, or bone will be candidates for
      treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion
      site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral
      therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same
      Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient's tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3

          -  Patient must have metastasis at one or more of the following sites: bone, liver, lymph
             node and/or lung. No more than five lesions will be treated.

          -  Histological confirmation of malignancy (primary or metastatic tumor).

          -  Patient may have any prior therapy allowed aside from having had prior radiotherapy to
             the treatment site (see exclusion criteria 5.2.3).

          -  Patient must be ≥ 18 years of age.

          -  Patient must have a life expectancy ≥ 9 months.

          -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          -  Patient must have normal organ and marrow function.

          -  Patient must have the ability to understand and the willingness to sign a written
             informed consent document.

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering
             the study

          -  Patients receiving any other investigational agents

          -  Patient who has had any prior radiotherapy to the treatment site(s)

          -  Patients taking drugs that are contraindicated with nelfinavir, including any of the
             following:

        Amiodarone, Quinidine, Rifampin, Dihydroergotamine, Ergonovine, Ergotamine,
        Methylergonovine, Hypericum perforatum (St. John's wort), Lovastatin, Simvastatin,
        Pimozide, Midazolam, Triazolam

          -  Women of child bearing potential who refuse to take a pregnancy test prior to
             treatment

          -  Participation in another concurrent treatment protocol while being treated on this
             protocol and through to 3 months after treatment on this protocol has ended

          -  Pregnant women

          -  Inability to understand the informed consent document

          -  Inability to sign the informed consent document

          -  Poor liver function suggestive of cirrhosis or steatohepatitis