Vaccine Therapy of Prostate Cancer Patients With Recombin... | NCT00705835

Status Module

Name	Class
PSMA Development Corp, LLC	UNKNOWN

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	This is an ascending, multiple dose study in up to 18 patients. As many as eight patients are planned at each of two dose levels, intrapatient dose escalation is not allowed. Six patients will start on 50μg rsPSMA +0.5 mg Alhydrogel® Weeks 1,2,3 and 7.	Biological: rsPSMA protein plus Alhydrogel® vaccine
2	Experimental	This is an ascending, multiple dose study in up to 18 patients. As many as eight patients are planned at each of two dose levels, intrapatient dose escalation is not allowed. Eight patients will start on 250μg rsPSMA + 1.0 mg Alhydrogel Weeks 1,2,3 and 7	Biological: rsPSMA protein plus Alhydrogel® vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rsPSMA protein plus Alhydrogel® vaccine	Biological	The assigned dose of rsPSMA protein plus Alhydrogel® vaccine will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4-week break and then a fourth vaccination during week 7. The vaccination site will rotate to a different quadrant with each administration.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Is to investigate the safety and tolerability of treatment with increasing dose levels of rsPSMA protein when administered with the adjuvant Alhydrogel®.		conclusion of study

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the immune response to increasing dose levels of rsPSMA protein.		conclusion of study
To study the pattern of change in PSA after vaccination.		conclusion of study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.