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Study Topics
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Sponsors and Collaborators: |
Bhardwaj, Nina, M.D. Cancer Research Institute |
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Information provided by: | Bhardwaj, Nina, M.D. |
ClinicalTrials.gov Identifier: | NCT00821652 |
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 or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to see if the patient's body's defense (immune) system can be boosted (strengthened) by this vaccine and if the addition of resiquimod to the vaccine makes this more likely.
Condition | Intervention | Phase |
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Tumors |
Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 26 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose-esclation
Part I represents a dose-escalation part with topical resiquimod in an open-label fashion.
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Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod
Part I: a cohort of 3 patients to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical resiquimod 1000 mg of the 0.2% gel on days 1, and 3. If no DLT observed, we will proceed to cohort 2 with Resiquimod dosing on days 1,3 and 5. If DLT is found in the second cohort, the trial will proceed to Part II; with the limited dosing for days 1 and 3 only, as used in the first cohort. If no DLT is found in second cohort, the trial will proceed to Part II with Resiquimod dosing for days1, 3 and 5.
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2: Experimental
Part II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I.
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Drug: NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo
Part II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I. The cycles will be repeated every 3 weeks for a total of 4 cycles (on Study week 1, 4, 7 and 10). All procedures may occur within + 3 days of the planned date.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients will be eligible for enrollment if they fulfill the following criteria:
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
Exclusion Criteria
Patients will be excluded from the study if they fulfill any of the following criteria:
Contact: Nina Bhardwaj, MD, PhD | 212-263-5814 | nina.bhardwaj@nyumc.org |
Contact: Anna Pavlick, DO | 212-731-5431 | anna.pavlick@nyumc.org |
United States, New York | |
NYU Clinical Cancer Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: Juliet Escalon, RN, ANP, OCN 212-263-4401 juliet.escalon@nyumc.org | |
Contact: Anna Pavlick, DO 212-731-5431 anna.pavlick@nyumc.org | |
Sub-Investigator: Farbod Darvishian, MD | |
Sub-Investigator: David O'Neill, MD | |
Sub-Investigator: Catherine Diefenbach, MD | |
Sub-Investigator: Patrick Ott, MD, PhD | |
Sub-Investigator: Leonard Liebes, PhD | |
Sub-Investigator: Sacha Gnjatic, PhD | |
Sub-Investigator: Achim Jungbluth, MD |
Principal Investigator: | Nina Bhardwaj, MD, PhD | NYU Langone Medical Center |
Study Director: | Anna Pavlick, DO | NYU Cancer Center |
Responsible Party: | NYU Langone Medical Center ( Nina Bhardwaj, MD, PhD ) |
Study ID Numbers: | NYU 05-409 |
Study First Received: | January 12, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00821652 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tumor NY-ESO-1 expression Tumors that often express NY-ESO-1. |
Adjuvants, Immunologic |