NCT00616291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2006

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

5.3 years

First QC Date

February 14, 2008

Last Update Submit

November 5, 2012

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Tolerability

  • Toxicity

Secondary Outcomes (1)

  • Immunological response

Study Arms (3)

Group I

EXPERIMENTAL

MHC Class I binding peptide at 1000 mcg

Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

Group II

EXPERIMENTAL

MHC Class II binding peptide at 1000 mcg

Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

Group III

EXPERIMENTAL

Combination MHC Class I and II binding peptide at 1000 mcg each

Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

Interventions

NY-ESO-1/LAGE-1 HLA class I/II peptide vaccineBIOLOGICAL
Group IGroup IIGroup III

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Sonpavde G, Wang M, Peterson LE, Wang HY, Joe T, Mims MP, Kadmon D, Ittmann MM, Wheeler TM, Gee AP, Wang RF, Hayes TG. HLA-restricted NY-ESO-1 peptide immunotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2014 Apr;32(2):235-242. doi: 10.1007/s10637-013-9960-9. Epub 2013 Apr 23.

    PMID: 23609828DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Teresa G. Hayes, MD, PhD

    Veterans Affairs Medical Center - Houston

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 15, 2008

Study Start

April 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

US(1)