Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer - Full Text View

Sponsor:	Baylor College of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00616291

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Tolerability [ Designated as safety issue: Yes ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunological response [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616291

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297

Sponsors and Collaborators

Baylor College of Medicine

National Cancer Institute (NCI)

Investigators

Study Chair:

Teresa G. Hayes, MD, PhD

Veterans Affairs Medical Center - Houston

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000579579, BCM-H-17274, BCM-SPORE-11-01-30-14
Study First Received:	February 14, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00616291 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009