Vaccine Therapy Plus QS21 in Treating Patients With Prostate Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: MUC-2-Globo H-KLH conjugate vaccine Biological: QS21 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates Plus The Immunological Adjuvant QS21 |
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | March 2002 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: MUC-2-Globo H-KLH conjugate vaccine Biological: QS21 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Susan Slovin, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00036933 History of Changes |
| Other Study ID Numbers: | 01-140, P30CA008748, MSKCC-01140, NCI-G02-2064 |
| Study First Received: | May 13, 2002 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
stage III prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Adjuvants, Immunologic QS 21 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013