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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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Is to investigate the safety and tolerability of treatment with increasing dose levels of rsPSMA protein when administered with the adjuvant Alhydrogel®.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Susan Slovin, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

02-072

NCT ID:

NCT00705835

Start Date:

January 2003

Completion Date:

January 2008

Related Keywords:

  • Prostate Cancer
  • Prostate
  • ALHYDROGEL
  • RS-PSMA
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021