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About
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.
Full description
Despite a modest improvement in survival with available chemotherapy treatments, androgen-independent metastatic prostate cancer remains essentially incurable.
Several changes in gene function that characterize malignancy have been identified. For example the p53 gene in normal tissue lessens the risk of cancer through growth arrest or cell suicidal programs. Thus the silenced p53 gene present in cancer tissue contributes to the growth of the cancer. In addition when the p53 gene is silenced, a cell survival pathway, controlled by the NF-kB gene, is activated leading increased cell survival.
Quinacrine can activate p53 and inhibit NF-kB, thus reestablishing cell suicidal programs and decreasing cell survival in cancer tissue. Moreover, quinacrine is effective against several prostate tumor cell lines in vitro, and has anti-tumor effects against prostate cancer xenografts in mice.
Enrollment
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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).
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:
ECOG performance status 0-2 (see Appendix 4)
Patients must have adequate organ and bone marrow function as defined below:
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
Primary purpose
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31 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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