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Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of Glycosylated MUC-2-KLH Peptide Conjugate Vaccine


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

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Trial Information

Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of Glycosylated MUC-2-KLH Peptide Conjugate Vaccine


OBJECTIVES: I. Determine if immunization with glycosylated MUC-2 antigen with keyhole limpet
hemocyanin (KLH) conjugate plus immunological adjuvant QS21 induces an antibody, helper T
cell, and/or cytotoxic T cell response against glycosylated MUC-2 in patients with
progressive prostate cancer. II. Determine the safety of this treatment regimen in this
patient population. III. Determine the effect of glycosylated MUC-2 antigen with KLH
conjugate on the T cell response against MUC-2 and by skin testing in these patients. IV.
Assess the post immunization changes in prostate specific antigen levels and other objective
parameters of disease including radionuclide bone scan and/or measurable disease in these
patients.

OUTLINE: Patients receive vaccination with glycosylated MUC-2 antigen with keyhole limpet
hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3,
7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year
or until disease progression.

PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Disease progression with
3 or more rising PSA levels at least 2 weeks apart with greater than 50% rise above the
baseline PSA, despite prostatectomy or radiotherapy Disease progression following primary
therapy including surgery or radiotherapy with or without neoadjuvant androgen ablation
allowed OR Intermittent hormonal therapy with noncastrate levels of testosterone (greater
than 50 ng/mL) allowed No soft tissue and/or bone disease OR No androgen independence
without evidence of radiographic disease No change in hormonal therapies (excluding
therapies to maintain castrate testosterone levels) including prednisone or dexamethasone
within 2 weeks of study No symptomatic or anticipatory (within 6 months) symptomatic
disease No active CNS or epidural tumor No radiographic evidence of metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper
limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at
least 40 mL/min Cardiovascular: No New York Heart Association class III or IV heart
disease Pulmonary: No severe debilitating pulmonary disease Other: No other active
malignancy within the past 5 years except nonmelanoma skin cancer No infection requiring
antibiotics No seafood allergies No positive stool guaiac except for hemorrhoids or
history of radiotherapy induced proctitis No narcotic dependent pain

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy and recovered At least 8 weeks since prior suramin and/or plasma
concentration below 50 microgram/mL Endocrine therapy: See Disease Characteristics
Recovered from prior hormonal therapy Concurrent replacement hydrocortisone following
prior suramin allowed Radiotherapy: See Disease Characteristics At least 4 weeks since
prior radiotherapy and recovered Surgery: See Disease Characteristics Recovered from prior
surgery

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

99-056

NCT ID:

NCT00004929

Start Date:

September 1999

Completion Date:

June 2008

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021