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Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
Official Title  Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.

Secondary

  • Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
  • Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
  • Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.

OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure  Tolerability [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Immunological response [ Designated as safety issue: No ]
Condition  Prostate Cancer
Intervention  Drug: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  18
Start Date  April 2006
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer with evidence of progressive disease despite hormonal therapy (i.e., hormone-refractory prostate cancer)

    • Metastatic disease
    • Progressive disease defined by any of the following:

      • New bone lesion on bone scan
      • Progression of nodal or soft tissue as evidenced by standard radiographic methods, i.e., CT scan or MRI
      • A 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart, with stable and measurable disease
  • Castrate serum levels of testosterone < 50 ng/dL
  • If patient was receiving anti-androgen therapy, in addition to luteinizing hormone-releasing hormone (LHRH) agonist therapy, the evidence of progressive disease should persist after a trial of anti-androgen withdrawal

    • Treatment with LHRH agonist to maintain androgen ablation must continue throughout this trial
  • Baseline PSA ≥ 10 ng/mL
  • All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status

    • Patients must be typed for HLA-DR4, DR13, DP4, or HLA-A2 haplotypes
  • No active brain metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 10 mg/dL
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 mg/dL
  • SGPT ≤ 3 times upper limit of normal
  • Serum creatinine ≤ 2 mg/dL
  • Wiling to be followed at Baylor College of Medicine
  • No serious intercurrent medical illness
  • No history of primary or secondary immunodeficiency
  • No active systemic infection
  • No known hepatitis B surface antigen, hepatitis C, or HIV antibody positivity
  • No history of cardiac arrhythmia or ischemic heart disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 6 weeks since prior immunotherapy (including anti-androgen therapy) and recovered
  • More than 28 days since prior chemotherapy
  • No concurrent immunosuppressive drugs such as systemic corticosteroids
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00616291
Organization ID CDR0000579579
Secondary IDs †† BCM-H-17274, BCM-SPORE-11-01-30-14
Study Sponsor  Baylor College of Medicine
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Teresa G. Hayes, MD, PhD     Veterans Affairs Medical Center - Houston    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2008
First Received Date  February 14, 2008
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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