Quinacrine Treatment in Patients With Androgen-Independent Prostate Cancer
Condition: Prostatic Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Quinacrine
Intervention description: 100 mg daily
Intervention MeSH terms: Quinacrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of Prostate; Prostate Cancer; Cancer of the Prostate; Neoplasms, Prostate; Neoplasms, Prostatic; Prostate Neoplasms; Prostatic Cancer; Androgen-Independent Prostate Cancer

Summary:

      The purpose of this study is to determine whether quinacrine is effective in the treatment of
      Androgen-Independent Prostate Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be males, at least 18 years of age, with pathologically confirmed
             adenocarcinoma of the prostate

          -  Patients must have evidence of androgen-independent metastatic prostate cancer (AIMPC)
             following standard antiandrogen withdrawal. AIMPC will be defined as the category of
             patients with metastatic prostate cancer with radiologic evidence of metastases (bone
             scan, CT, etc.) and castrate levels of testosterone (~ 50 ng/dL).

               1. All patients must be receiving ongoing therapy to ensure testicular androgen
                  suppression (LHRH agonists therapy or bilateral orchiectomy).

               2. All patients receiving anti-androgen therapy [e.g., flutamide (Eulexin),
                  bicalutamide (Casodex), or nilutamide (Nilandron)] must have initiated therapy at
                  least 3 months (90 days) prior to the Baseline visit.

          -  Patients must have received prior docetaxel-based or mitoxantrone-based chemotherapy,
             or refused or been ineligible for chemotherapy. Previous chemotherapy treatments must
             be completed at least 4 week prior to Screening, and patients must not have any
             residual therapy-related toxicities present at Screening.

          -  Patients must have evidence of disease progression defined as any of the following:

               1. New sites of metastatic disease on radiographic imaging (bone scan or CT scan of
                  chest/abdomen/pelvis) as determined by the referring physician.

               2. PSA progression, defined as a 50% or greater rise in PSA value over a baseline
                  level of at least 1.0 ng/mL, confirmed after an interval of at least two weeks.

          -  ECOG performance status 0-2 (see Appendix 4)

          -  Patients must have adequate organ and bone marrow function as defined below:

               1. Absolute neutrophil count greater than 1500/mL

               2. Platelets greater than 100,000/mL

               3. Serum creatinine less than 2.0 mg/dL

               4. Total bilirubin less than 1.5 mg/dL

               5. AST (SGOT) and ALT (SGPT) less than 2 times the ULN [less than 5 times the ULN if
                  liver metastases are present].

          -  Sexually active men whose sexual partners are women of childbearing potential must
             agree to use a medically acceptable form of barrier contraception or abstinence during
             their participation in the study and for at least six weeks after study drug
             discontinuation.

          -  Written informed consent/HIPAA authorization must be provided prior to the performance
             of any study-related procedures.

        Exclusion Criteria:

          -  Prior allergic reactions or a history of intolerance attributed to quinacrine or other
             acridine derivatives

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, hematological disorders, hepatic disease, or psychiatric illness/social
             situations that would limit compliance with study requirements.

          -  Lifetime history of porphyria or psoriasis

          -  Documented glucose-6-phosphate dehydrogenase deficiency

          -  Lifetime history of seizure disorder (except infant febrile seizures)

          -  Lifetime history of schizophrenia, bipolar disorder, or any other psychotic disorders.

          -  Lifetime history of dermatitis as an allergic/toxic reaction to any medication

          -  Clinical evidence of CNS metastases

          -  Patients with a history of any malignancy (other than basal, squamous cell cancers and
             Ta bladder cancers) within 5 years of baseline visit

          -  Any grade 2 sensory neuropathy

          -  QTc (Bazett) >450 msec

          -  Patients with NYHA class 3 or 4 failure

          -  Patients with myocardial infarction or acute coronary syndrome within the previous 6
             months

          -  Patients who require anti-arrhythmic treatment