Perifosine in Treating Patients With Recurrent Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: perifosine; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase II trial to study the effectiveness of perifosine in treating patients who have
      recurrent prostate cancer. Drugs used in chemotherapy such as perifosine use different ways
      to stop tumor cells from dividing so they stop growing or die
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             prostate

          -  Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy
             (either radical prostatectomy and/or pelvic radiation) with no clinical or
             radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed by
             two consecutive increases, each measured at least 2 weeks apart; only patients with a
             biochemical (PSA) recurrence with no physical exam or radiographic evidence of local
             or distant relapse are eligible

          -  Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as
             long as neither lasted for more than 9 months; androgen deprivation therapy must have
             been completed at least one year prior to registration; patients could not have had a
             rising PSA at the time that neoadjuvant or adjuvant therapy was stopped

          -  Life expectancy of greater than 3 months

          -  Karnofsky performance status > 60%

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,00/uL

          -  Total bilirubin =< 1.5 mg/dL

          -  AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

          -  Computed tomography scan or MRI of the pelvis negative for metastatic disease within 3
             months prior to registration

          -  Bone scan negative for metastatic disease within 3 months prior to registration

          -  Chest PA and lateral films negative for metastatic disease within 3 months prior to
             registration

          -  Prior vaccine therapy is allowed if completed at least 6 months prior to registration

          -  Men enrolled in this trial must agree to use adequate contraception prior to study
             entry and for the duration of study participation

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had any prior cytotoxic chemotherapy

          -  Patients may not be receiving any other investigational agents

          -  Patients receiving concurrent chemotherapeutic agents, biological response modifiers,
             radiation therapy, corticosteroid or hormonal therapy; no complementary or alternative
             therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies taken for the
             purpose of treating prostate cancer) may be given during protocol treatment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to perifosine

          -  Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with perifosine;
             appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated

          -  No prior malignancy is allowed except for the following: adequately treated basal cell
             or squamous cell skin cancer, in situ carcinoma of any site, adequately treated stage
             I or II cancer from which the patient is currently in complete remission, or any other
             cancer from which the patient has been disease-free for 5 years