NY-ESO Phase I Study for Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2006 |
| End Date: | December 2016 |
| Contact: | Teresa Joe |
| Email: | tjoe@bcm.edu |
| Phone: | 713-794-1414 |
Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
Prostate cancer is the most common type of cancer found in American men, other than skin
cancer. The American Cancer Society estimates that there will be about 218,890 new cases of
prostate cancer in the United States in 2007. About 27,050 men will die of this disease.
Prostate cancer is the second leading cause of cancer death in men. Lung cancer is the
first. While 1 man in 6 will get prostate cancer during his lifetime, only 1 man in 34 will
die of this disease. The death rate for prostate cancer is going down, and the disease is
being found earlier as well.
There is a great need for new treatment options for prostate cancer that can be given
safely. One alternative to widely used conventional cancer treatments is to utilize the
ability of the patient's immune system to target and kill tumor cells. A vaccine is a
compound designed to strengthen the immune system (the cells and substances that protect the
body from infection and foreign matter) to fight an illness such as infections or cancer.
This vaccine is called NY-ESO-1 protein. NY-ESO protein (an antigen, which is a compound
that is recognized by the immune system) is found in many cancers. Proteins such as NY-ESO-1
and LAGE-1 and their fragments are the targets the immune system needs to recognize cancer
cells. If the immune system can recognize these antigens (foreign substances) it may be able
to kill the cells that carry them. NY-ESO-1 can be found at different stages of cancers, and
is likely to be expressed (shown) at some point in the lifecycle of these types of cancer
(that are eligible for this study). Therefore this study tries to boost (strengthen) the
immune system toward NY-ESO-1 protein regardless of whether it is found in the tumor or not.
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
III).
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
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