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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705835
• Other study ID #: 02-072
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2008
• Last updated: January 6, 2012
• Start date: January 2003
• Est. completion date: January 2008

Study information

• Verified date: January 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	PSMA Development Corp, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate the immune response to increasing dose levels of rsPSMA protein.		conclusion of study	No
Secondary	To study the pattern of change in PSA after vaccination.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center