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Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer - Article


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Vaccine



Clinical Trial: Vaccine Therapy Plus Biological Therapy in Treating Patients With Relapsed Prostate Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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:

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

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


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

Study chairs or principal investigators

Susan Slovin, MD, PhD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068596; MSKCC-00064; NCI-G01-1940
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

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November 18, 2008



Page Updated: September 6, 2005
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