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NCT Number: NCT00705835

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rsPSMA protein plus Alhydrogel® vaccine

Biological

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 outcomes

  1. 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 outcomes

  1. To evaluate the immune response to increasing dose levels of rsPSMA protein.

    Time frame: conclusion of study

  2. To study the pattern of change in PSA after vaccination.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • PSMA Development Corp, LLC

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 26, 2008
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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