Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
January 6, 2012 updated by: Memorial Sloan Kettering Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
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.
|
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.
|
|
EXPERIMENTAL: 2
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the immune response to increasing dose levels of rsPSMA protein.
Time Frame: conclusion of study
|
conclusion of study
|
|
To study the pattern of change in PSA after vaccination.
Time Frame: conclusion of study
|
conclusion of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (ACTUAL)
January 1, 2008
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
June 24, 2008
First Submitted That Met QC Criteria
June 24, 2008
First Posted (ESTIMATE)
June 26, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 9, 2012
Last Update Submitted That Met QC Criteria
January 6, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.