Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center PSMA Development Corp, LLC
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00705835

Purpose

The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, such as cancer. Your immune system is made up of many different types of cells which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection into or under the skin. It is made up of several parts. The first part is PSMA, a protein present in many cancers, especially prostate cancer. It is referred to as rsPSMA when made in a laboratory for this study and is mixed with a material called Alhydrogel® (aluminum hydroxide suspension) which helps the immune system to make more cancer-fighting cells.

Condition	Intervention	Phase
Prostate Cancer	Biological: rsPSMA protein plus Alhydrogel® vaccine	Phase I

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Aluminum hydroxide Algeldrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel: A Trial Studying RsPMSA Doses

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Is to investigate the safety and tolerability of treatment with increasing dose levels of rsPSMA protein when administered with the adjuvant Alhydrogel®. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the immune response to increasing dose levels of rsPSMA protein. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
To study the pattern of change in PSA after vaccination. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	January 2003
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.
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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705835

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

PSMA Development Corp, LLC

Investigators

Principal Investigator:

Susan Slovin, MD,PhD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Susan Slovin, MD PhD )
Study ID Numbers:	02-072
Study First Received:	June 24, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00705835
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Prostate
ALHYDROGEL
RS-PSMA

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Aluminum Hydroxide

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009