Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy Plus QS21 in Treating Patients with Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	MSKCC-99040 NCI-G00-1773, NCT00005632

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.

Entry 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

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

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

Expected Enrollment

A total of 25 patients will be accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Susan Slovin, MD, PhD, Protocol chair		Ph: 646-422-4470; 800-525-2225

Registry Information
Official Title		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
Trial Start Date		1999-06-08
Trial Completion Date		2009-03-10
Registered in ClinicalTrials.gov		NCT00005632
Date Submitted to PDQ		2000-03-15
Information Last Verified		2009-04-01

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