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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rsPSMA protein plus Alhydrogel® vaccine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, ALHYDROGEL, RS-PSMA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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.

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

Outcomes

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®.

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2008
Last Updated
January 6, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
PSMA Development Corp, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00705835
Brief Title
Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
PSMA Development Corp, LLC

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, ALHYDROGEL, RS-PSMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
rsPSMA protein plus Alhydrogel® vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the immune response to increasing dose levels of rsPSMA protein.
Time Frame
conclusion of study
Title
To study the pattern of change in PSA after vaccination.
Time Frame
conclusion of study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Slovin, MD,PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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