Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer

Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with QS21 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with QS21 in treating patients who have prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Biological: QS21; Biological: MUC-2-Globo H-KLH conjugate vaccine

Detailed Description

OBJECTIVES:

• Determine the safety of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 in patients with prostate cancer.
• Determine the antibody response in patients treated with this vaccination therapy.
• Assess post-immunization changes in PSA levels and other objective parameters of disease (radionuclide bone scan) in patients treated with this vaccination therapy.

OUTLINE: Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50.

Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer

• Disease progression after primary surgery (radical prostatectomy) or radiotherapy with or without prior neoadjuvant androgen ablation

  • Minimum of 3 rising PSA values, taken at least 2 weeks apart, with more than a 50% rise in PSA level above the baseline value (1.0 ng/mL post -prostatectomy or 2.0 ng/mL post-radiotherapy)
  • Received prior intermittent hormonal therapy after prior primary therapy
  • Non-castrate levels of testosterone (more than 50 ng/mL)
• Evaluable disease (by serial changes in PSA)
• No radiographic evidence of metastatic disease
• No active CNS or epidural tumor
• No soft tissue and/or bone disease
• No androgen-independence with no evidence of radiographic disease
• May not be symptomatic or anticipated to develop symptoms within 6 months of study entry

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• At least 6 months

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL
• 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 clinically significant cardiac disease (New York Heart Association class III or IV)

Pulmonary:

• No severe debilitating pulmonary disease

Other:

• No allergy to seafood (shellfish)
• No other active malignancy within the past 5 years except nonmelanoma skin cancer
• No infection requiring antibiotics
• No narcotic-dependent pain
• No positive stool guaiac unless associated with hemorrhoids or prior documented radiation-induced proctitis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• See Disease Characteristics
• See Chemotherapy
• At least 2 weeks since change in hormonal therapy (e.g., prednisone or dexamethasone) except to maintain castrate levels of testosterone

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent irradiation of only measurable lesion

Surgery:

• See Disease Characteristics
• No concurrent surgery of only measurable lesion

Other:

• Recovered from prior therapy
• At least 8 weeks since prior suramin and/or documented plasma concentration of suramin if less than 50 micrograms/mL (replacement hydrocortisone allowed)
• No other concurrent oncolytic agents
• No concurrent immunosuppressive therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: vaccine; Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant QS21 subcutaneously once weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity. Patients whose antibody titers against Globo-H or MUC-2 antigens fall below 1/40 and who have no disease progression may receive a seventh vaccination after week 50. Patients are followed every 3 months for 1 year or until biochemical relapse or radiographic disease progression.

Biological: QS21; Biological: MUC-2-Globo H-KLH conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
response	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 13, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): March 25, 2013
• Last Update Submitted That Met QC Criteria: March 22, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: stage III prostate cancer; recurrent prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 01-140; P30CA008748 (U.S. NIH Grant/Contract); MSKCC-01140; NCI-G02-2064