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Clinical Trial: Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent prostate cancer | Drug: Globo H-GM2-Lewis-y-MUC1-32-mer-TF(c)-Tn(c)-KLH conjugate vaccine Drug: QS21 Procedure: biological response modifier therapy Procedure: non-specific immune-modulator therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of a Multivalent Conjugate Vaccine With Adjuvant QS21 in Patients With Biochemically Relapsed Prostate Cancer
OBJECTIVES:
- Determine the safety of a multivalent conjugate vaccine comprising Globo H, GM2, Lewis-y, MUC-1-32-mer, TF(c), and Tn(c) antigens conjugated to keyhole limpet hemocyanin (KLH) with adjuvant QS21 in patients with biochemically relapsed prostate cancer.
- Measure the antibody response against the individual components of the vaccine and correlate the response to subsequent clinical course in patients treated with this vaccine.
- Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of the disease in these patients.
OUTLINE: Patients receive Globo H, MUC-1-32mer, GM2, Lewis-y, Tn(c), TF(c)-KLH conjugate vaccine with adjuvant QS21 subcutaneously weekly on weeks 1, 2, 3, 7, 19, 31, 43, and 55.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 6 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Biochemically progressive disease after primary therapy, including surgery or radiotherapy, with or without neoadjuvant androgen ablation
- Log of prostate-specific antigen (PSA) slope greater than 0.15 as determined by at least 3 measurements taken at 2-week intervals within 12 months
- Minimal baseline PSA value prior to study:
- Post-prostatectomy: 0.1 ng/mL
- Post-radiotherapy: 1.0 ng/mL
- Intermittent hormonal therapy: 1.0 ng/mL
- Patients with prior intermittent hormonal therapy after primary therapy and non-castrate levels of testosterone (greater than 50 ng/mL) are eligible
- No radiographic evidence of metastatic disease
- Concurrent registration to MSKCC-90040 required
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 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 clinically significant cardiac disease (New York Heart Association class III-IV)
Pulmonary:
- No severe debilitating pulmonary disease
Other:
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or melanoma in situ
- No allergy to seafood
- No narcotic-dependent pain
- No infection requiring antibiotics
- No positive stool guaiac except hemorrhoids or history of documented radiation induced proctitis
PRIOR CONCURRENT THERAPY: Biologic therapy:
- No prior vaccine therapy except on phase I monovalent trial at Memorial Sloan Kettering Cancer Center
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy to only measurable lesion
Surgery:
- See Disease Characteristics
- No concurrent surgery of only measurable lesion
Other:
- Recovered from prior therapy
- No other concurrent oncolytic agents
Location Information
Susan Slovin, MD, PhD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: February 2004
Last Updated: October 13, 2004
Record first received: May 6, 2001
ClinicalTrials.gov Identifier: NCT00016120
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- (National Women's Health Information Center, OWH, HHS)
- Add Hepatitis B Vaccination to Your Back to School List (National Center for Infectious Diseases, CDC, OPHS, HHS)

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