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Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate


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

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Trial Information

Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate


OBJECTIVES: I. Determine if immunization with glycosylated MUC-1 antigen containing MUC-1
(106) with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an
antibody, helper T cell and/or cytotoxic T cell response against MUC-1 in patients with
prostate cancer expressing MUC-1. II. Determine post-immunization changes in PSA levels and
other objective parameters or disease (radionuclide bone scan and/or measurable disease if
present) in these patients after receiving this therapy.

OUTLINE: Patients receive glycosylated MUC-1 antigen containing MUC-1 (106) 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 documented disease progression.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer No radiographic evidence
of metastatic disease Must show signs of disease progression 3 or more rising PSA values
documented, taken at no less than weekly intervals, to greater than 50% above baseline PSA
PSA at least 1.0 ng/mL (post prostatectomy) OR 2.0 ng/mL (post radiation) Evaluable
disease by serial changes in PSA Progression after primary therapy to include surgery or
radiotherapy (with or without neoadjuvant androgen ablation), or intermittent hormonal
therapy with noncastrate levels of testosterone (greater than 50 ng/mL) allowed No soft
tissue and/or bone disease or androgen independent disease with no evidence of
radiographic disease No symptomatic disease or anticipated to be symptomatic within 6
months No active CNS or epidural tumor

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-IV heart disease
Pulmonary: No severe debilitating pulmonary disease Other: No other malignancy within past
5 years except nonmelanoma skin cancer No concurrent infection requiring antibiotics No
narcotic dependent pain No positive stool guaiac excluding hemorrhoids No history of
documented radiation induced proctitis No allergy to seafood

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No
other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and
recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At
least 2 weeks since prior changes in hormonal therapy including prednisone or
dexamethasone At least 8 weeks since prior suramin OR documented plasma concentration less
than 50 mg/mL (replacement doses of hydrocortisone allowed) Radiotherapy: See Disease
Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent
radiotherapy to only measurable lesion Surgery: See Disease Characteristics No concurrent
surgery Other: No other concurrent anticancer agents

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:

99-040

NCT ID:

NCT00005632

Start Date:

June 1999

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021