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A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG7909 and Montanide® ISA-51 in Patients With Cancers That Often Express NY-ESO-1.

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

A Phase I Study Using Vaccination With NY-ESO-1 Recombinant Protein Mixed With CpG7909 and Montanide® ISA-51 in Patients With Cancers That Often Express NY-ESO-1.

You will receive an investigational (research) cancer vaccine every 3 weeks for a total of 4
treatments. It is given by injection underneath your skin in an extremity (leg or arm). 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 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 your tumor or not.

Since we do not know whether different doses of the NY-ESO-1 protein may result in varying
degrees of immune stimulation, we will be randomizing (that is, at the flip of a coin or, in
other words, by chance) you may receive either the lower dose of NY-ESO-1 protein (100 µg)
or the higher dose (400 µg.) There is a 50:50 chance that you will receive the lower versus
the higher dose. At this time we have no way of knowing whether there will be any real
difference in the effects between these doses. In either case you will be receiving the
NY-ESO-1 protein. In all studies to date, only the 100 µg dose has been used. There is no
reason to think that the higher dose will be toxic, nor is there any reason at this time to
think that the higher dose will be more effective at the immunological level, although it
may be, which is the reason for comparing the effects of these two doses of protein.

The NY-ESO-1 protein vaccine is mixed with 2 substances, called adjuvants (the full names
are: CPG 7909 and Montanide ISA-51). Adjuvants are substances to increase the vaccine's
ability to stimulate the immune system. By adding two adjuvants to the vaccine, it is hoped
that the boosting of the immune system will be especially effective.

It is important to understand, that vaccines are only experimental (investigational,
research) for the treatment of cancer. They are not approved by the Food and Drug
Administration (FDA) as treatment. Therefore they are only offered in clinical trials.

All tests and treatments will be performed as an outpatient.

Inclusion Criteria:

Patients will be eligible for enrollment if they fulfill the following criteria:

1. Histological diagnosis of hepatocellular carcinoma, bladder cancer, breast cancer,
non-small lung cancer (NSCLC), melanoma, sarcoma, prostate cancer, esophageal cancer,
or ovarian cancer, independent of NY-ESO-1 expression in a tumor biopsy

OR Histological diagnosis of other types of cancers, provided NY-ESO-1 or LAGE-1
expression can be shown in a tumor biopsy.

2. At least 4 weeks since surgery prior to first dosing of study agent.

3. Laboratory values within the following limits:

- Hemoglobin > 11.0 g/dL

- Neutrophil count > 1.5 x l09/L

- Lymphocyte count > Lower limit of institutional normal

- Platelet count > 80 x l09/L

- Serum creatine < 2.0 mg/dL

- Serum bilirubin < 2 x upper limit of institutional normal

- AST/ALT < 2 x upper limit of institutional normal

4. Patients must have a Karnofsky performance status of >70%.

5. Life expectancy > 6 months.

6. Age > 18 years.

7. Able and willing to give witnessed, written informed consent for participation in the
trial (see Section 12.2)

Exclusion Criteria:

Patients will be excluded from the study if they fulfill any of the following criteria:

1. Clinically significant heart disease (i.e. NYHA class 3 congestive heart failure;
myocardial infarction within the past six months; unstable angina; coronary
angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac

2. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding

3. Previous bone marrow or stem cell transplant.

4. History of immunodeficiency disease or autoimmune disease except vitiligo.

5. Metastatic disease to the central nervous system, unless treated and stable.

6. Other malignancy within 3 years prior to entry into the study, except for treated
early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.

7. Known HIV, Hepatitis B or Hepatitis C positivity.

8. Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose
of study agent (6 weeks for nitrosoureas).

9. Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
(See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.)

10. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first dose of study agent.

11. Pregnancy or lactation.

12. Women of childbearing potential not using a medically acceptable means of

13. Psychiatric or addictive disorders that may compromise the ability to give informed

14. Lack of availability of the patient for immunological and clinical follow-up

Type of Study:


Study Design:

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

Outcome Measure:


Principal Investigator

Nina Bhardwaj, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

December 2006

Related Keywords:

  • Tumors
  • NY-ESO-1
  • Vaccine
  • Adjuvant or metastatic setting
  • Several tumor types eligible



NYU Clinical Cancer CenterNew York, New York  10016
NY Presbyterian- ColumbiaNew York, New York  10032