Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
PSMA Development Corp, LLC
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00705835
First received: June 24, 2008
Last updated: January 6, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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
|
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
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00705835 History of Changes |
| Other Study ID Numbers: | 02-072 |
| Study First Received: | June 24, 2008 |
| Last Updated: | January 6, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
Adjuvants, Immunologic Aluminum Hydroxide Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013