Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
NCT00616291CI-TRIAL-00008423completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group I
- description
- MHC Class I binding peptide at 1000 mcg
- interventionNames
- Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
- type
- EXPERIMENTAL
- label
- Group II
- description
- MHC Class II binding peptide at 1000 mcg
- interventionNames
- Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
- type
- EXPERIMENTAL
- label
- Group III
- description
- Combination MHC Class I and II binding peptide at 1000 mcg each
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 corticosteroidsReferences
Publications (1)
- DERIVEDSonpavde 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 23609828