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Phase I Randomized, Double-blind, Placebo-controlled Study of Topical Resiquimod as an Adjuvant for NY-ESO1 Protein+Montanide Vaccination in Patients With Tumors That Often Express NY-ESO-1


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumors

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Trial Information

Phase I Randomized, Double-blind, Placebo-controlled Study of Topical Resiquimod as an Adjuvant for NY-ESO1 Protein+Montanide Vaccination in Patients With Tumors That Often Express NY-ESO-1


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-escalation part with topical resiquimod in an open-label fashion. Part II represents
the randomized part.

In Part I, 2 cohorts are planned: If no dose-limiting toxicity (DLT) occurs by day 8 of the
last vaccination cycle in the last patient enrolled the first cohort, 3 additional patients
(cohort 2) will be enrolled. If no DLT occurs by day 8 of the last vaccination cycle in the
last patient enrolled the second cohort in Part I, the trial will proceed to Part II where
patients will be randomized.

Inclusion Criteria


Inclusion Criteria

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

1. 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

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

3. 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

4. Patients must have an ECOG performance status of <2 (ECOG criteria published in [46])

5. Life expectancy > 6 months.

6. Age > 18 years.

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

8. 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:

1. Serious illnesses, e.g., serious infections requiring antibiotics.

2. Previous bone marrow or stem cell transplant.

3. History of immunodeficiency disease (such as HIV) or autoimmune disease except
vitiligo.

4. Metastatic disease to the central nervous system.

5. Other malignancy prior to entry into the study.

6. No radiation therapy, prior biological therapy or surgery within 4 weeks prior to
first dose of study agent.

7. No prior chemotherapy or prior vaccine or immunotherapy.

8. 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'.)

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

10. Pregnancy or lactation.

11. Women of childbearing potential not using a medically acceptable means of
contraception.

12. Patients with known history of inflammatory skin disorders (e.g.,psoriasis, lupus)
that may be exacerbated by Resiquimod.

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary objectives of the study are to define the safety and immunogenicity of vaccination with NY-ESO-1 protein emulsified in Montanide® ISA-51 VG when given with or without the topical TLR 7/8 agonist resiquimod.

Outcome Time Frame:

Blood samples are obtained at baseline, 1 week after each vaccination, and at follow-up 1visit.

Safety Issue:

Yes

Principal Investigator

Nina Bhardwaj, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU Langone Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NYU 05-409

NCT ID:

NCT00821652

Start Date:

February 2009

Completion Date:

June 2013

Related Keywords:

  • Tumors
  • Tumor
  • NY-ESO-1 expression
  • Tumors that often express NY-ESO-1.

Name

Location

NYU Clinical Cancer CenterNew York, New York  10016