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Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)

Phase 1
18 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)

Nine subjects will participate in this Phase I study that is designed to evaluate the safety
and biology of class I and class II NY-ESO-1/LAGE-1 vaccine with an intent to offer a
therapeutic advantage. The treatment cycle is 6 subcutaneous injections administered every
other week for 12 weeks of NY-ESO-1/LAGE-1 vaccine (weeks 1, 3, 5, 7, 9, 11 (±3 days)). The
vaccinations will be given in the upper arm region, in a volume of 1 milliliter. The dose
will be 1000 mcg of peptide (1 mg). Patients will be evaluated for clinical/immunological
responses at weeks 5 and 11. The vaccine schedule is similar to that of many prior peptide
vaccine studies, in which the schedule was based on earlier animal studies but empirically
derived in human studies (32-34, 36-39).

The first patients will be enrolled to receive subcutaneous vaccination with either class I
or II NY-ESO-1/ LAGE-1 peptide (1000 mcg). Thus, the trial will test the toxicity of the
vaccine with 3 patients in each of 2 vaccine groups, one receiving Class I (group I) and the
other Class II peptide (group II). If no significant toxicity is observed after a treatment
cycle of 12 weeks, then three patients will receive a combination of both peptides (group

Inclusion Criteria:

- Male, aged 18 years or older, with metastatic prostate cancer that shows evidence
of progressive disease despite hormonal therapy.

- Testosterone levels less than 50ng/dl.

- Baseline PSA equal to or greater than 10 ng/ml.

- Must be typed for HLA-DR4, DR13, DP4, or HLA-A2 haplotypes.

- Zubrod Performance Status of less than or equal to 2.

- Life expectancy of at least 12 weeks.

- Absolute neutrophil count equal to or greater than 1500/mm3

- Hemoglobin equal to or greater than 10 mg/dl

- Platelet count equal to or greater than or equal to 100,000/mm3.

- Serum creatinine of equal to or less than 2 mg/dL.

- Willing to sign an informed consent indicating that they are aware of the
investigational nature of this study

- Willing to have follow-up visits at Baylor College of Medicine

Exclusion Criteria:

- No active brain metastases

- No serious medical illnesses

- No history of primary or secondary immunodeficiency or taking immunosuppressive drugs

- No active systemic infection.

- Must not be positive for hepatitis B surface antigen and Hepatitis C or HIV antibody

- No prior chemotherapy within 28 days

- No history of cardiac arrhythmia or ischemic heart disease

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progressive disease is a new bone lesion on bone scan, progression of nodal or soft tissue, or a 50% increase in prostate specific antigen (PSA) level from the nadir PSA level confirm twice and measured at least two weeks apart.

Outcome Time Frame:

Tumor evaluation assessment will be performed prior to vaccine 1 (week 1) and every 12 weeks.

Safety Issue:


Principal Investigator

Teresa G. Hayes, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

December 2016

Related Keywords:

  • Prostatic Neoplasms
  • Vaccine
  • Immunotherapy
  • NY-ESO-1
  • LAGE-1
  • Phase I Clinical Trial
  • Neoplasms
  • Prostatic Neoplasms



Baylor College of Medicine/Scott Department of Urology Houston, Texas  77030