Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
PSMA Development Corp, LLC
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Non-castrate metastatic patients must have biochemically progressive disease as defined by serial changes in PSA (with a serum testosterone \> or = to 180 ng/mL)following definitive primary therapy such as prostatectomy or radiation. Castrate metastatic patients must have biochemically progressive disease in the absence of radiographic evidence of disease progression with rising PSA values despite castrate (\<50 ng/mL) levels of testosterone following an adequate course of hormonal therapy. An adequate course of hormonal therapy is treatment with an LH-RH analog (with or without an anti-androgen) or orchiectomy.
Prostate cancer must be histologically confirmed by the Department of Pathology at MSKCC.
Karnofsky performance status \>70%.
Patients must have adequate organ function as defined by:
WBC \> or = to 3000/mm3, neutrophils \> or = to1000/mm3, platelet count \> or = to l00,000 mm3
Bilirubin \<2.0 mg/dl
Alkaline Phosphatase and SGOT \<3.0 times the upper limit of normal
Creatinine \< or = to 2.0 mg/dl
Hemoglobin \>9.0 g/dl
ALT \<2.5 times the upper limit of normal
Patients must be at least 18 years of age
Expected survival must be \>6 months
Patients must sign informed consent.
Non-castrate metastatic patients must have a serum testosterone \>180 ng/mL.
You may not be if
Radiographic evidence of disease progression.
Clinically significant cardiac disease (New York Heart Association Class III/IV or severe debilitating pulmonary disease).
Active CNS or epidural tumor.
An infection requiring antibiotic treatment.
Lymphopenia defined by lymphocytes \<1000/mm3.
Cancer related pain requiring the use of opioid containing analgesics.
Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis.
Concurrent treatment with nutritional or herbal supplements (e.g., PC SPES or similar agents) which could potentially confound the interpretation of study results.
History of an active secondary malignancy except for non-melanoma skin cancer.
Clareo Health | Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
