Status:
COMPLETED
Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination
Lead Sponsor:
Nina Bhardwaj
Collaborating Sponsors:
Cancer Research Institute, New York City
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with...
Detailed Description
There is no published data on the application of topical resiquimod in combination with an antigen in Montanide, therefore, this study includes a 2-part design where Part I represents a dose-escalatio...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients will be eligible for enrollment if they fulfill the following criteria:
- Histological diagnosis of surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma independent of NY-ESO-1 expression in a tumor biopsy
- At least 4 weeks since surgery prior to first dosing of study agent.
- Laboratory values within the following limits:
- Hemoglobin \> 10.0 g/dL Neutrophil count \> 1.5 x l09/L Lymphocyte count \> Lower limit of institutional normal Platelet count \> 80 x l09/L Serum creatinine \< 2.0 mg/dL Serum bilirubin \< 2 x upper limit of institutional normal AST/ALT \< 2 x upper limit of institutional normal
- Patients must have an ECOG performance status of \<2 (ECOG criteria published in \[46\])
- Life expectancy \> 6 months.
- Age \> 18 years.
- Able and willing to give written informed consent for participation in the trial (see Section 12.2)
- Patients enrolled in the adjuvant setting must have received standard curative therapy, e.g., surgery, radiation. Alternatively, patients can enter after refusing standard curative therapy only if therapy was clearly discussed with the treating physician or if they have failed another biologic therapy due to toxicity.
- Exclusion Criteria
- Patients will be excluded from the study if they fulfill any of the following criteria:
- Serious illnesses, e.g., serious infections requiring antibiotics.
- Previous bone marrow or stem cell transplant.
- History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
- Metastatic disease to the central nervous system.
- Other malignancy prior to entry into the study.
- No radiation therapy, prior biological therapy or surgery within 4 weeks prior to first dose of study agent.
- No prior chemotherapy or prior vaccine or immunotherapy.
- Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.)
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of contraception.
- Patients with known history of inflammatory skin disorders (e.g.,psoriasis, lupus) that may be exacerbated by Resiquimod.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00821652
Start Date
February 1 2009
End Date
December 1 2014
Last Update
January 8 2015
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029