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Vaccination of Prostate Cancer Patients With Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Vaccination of Prostate Cancer Patients With Thompson-Friedenreich [TF(c)]-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing TF(c)-KLH Doses

OBJECTIVES: I. Determine the optimal dose of Thompson-Friedenreich [TF(c)]-keyhole limpet
hemocyanin (KLH) conjugate plus adjuvant QS21 that induces an antibody response in patients
with prostate cancer. II. Determine the safety of the TF(c)-KLH conjugate prepared using an
MBS heterobifunctional linker plus QS21. III. Assess postimmunization changes in prostate
specific antigen levels and other objective parameters of disease in these patients.

OUTLINE: This is a dose escalation study. Patients receive TF(c)-KLH conjugate with adjuvant
QS21 subcutaneously weekly for 3 weeks, then once during weeks 7 and 19. Cohorts of 5
patients each receive escalating doses of TF(c)-KLH vaccine until the optimal dose, based on
antibody response, is reached. Patients are followed monthly for 6 months, then every 3
months for 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven progressive prostate cancer after primary
therapy Radiographic changes OR PSA at least 1.0 ng/mL and rising after prostatectomy OR
PSA at least 2.0 ng/mL and rising after radiotherapy OR PSA rising 50% during intermittent
hormonal therapy No metastatic disease by radiography No active CNS or epidural tumor
Registered on MSKCC-9040

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: WBC at least 3500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3.0 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 cardiac disease
Pulmonary: No severe debilitating pulmonary disease Other: No other active malignancy
within 5 years except nonmelanomatous skin cancer No infection requiring antibiotics No
narcotic dependent pain No positive stool guaiac excluding hemorrhoids No radiation
induced proctitis No allergy to seafood

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See
Disease Characteristics At least 2 weeks since change in hormonal therapy (except to
maintain castrate levels of testosterone), including prednisone or dexamethasone At least
8 weeks since prior suramin and/or serum concentration of suramin must be less than 50
micrograms/mL (replacement hydrocortisone allowed) Radiotherapy: See Disease
Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent
therapy to only measurable lesion Surgery: See Disease Characteristics No concurrent

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Susan Slovin, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 1998

Completion Date:

March 2009

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021