Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

NCT01079741 | Completed Phase 1 Results DMC

• 1 other identifier: GCO 13-1391
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.

Conditions

Melanoma

Keywords

Melanoma; Skin Cancer; Adjuvant Therapy; Oncogenesis; LAGE; Cancer Immunity; Neoplasms; Immunogenicity; Vaccine; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Phase I, Number of Participants With SAE and DLT

  Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).

  52 weeks

Secondary Outcomes (2)

• CD4+ and CD8+ Response

  Up to 52 weeks

• NY-ESO-1 Expression by IHC

  up to 52 weeks

Study Arms (2)

Dose-escalation component

EXPERIMENTAL

Phase I represents the dose-escalation component with Poly-ICLC given in combination with NY-ESO-1 and Montanide in an open-label fashion. The dose of Poly-ICLC will be increased stepwise from 0.35mg to 1.4mg while the dose of NY-ESO-1 antigen and Montanide will be held constant.

Biological: NY-ESO-1 protein; Poly-ICLC; Montanide

Phase II is the randomized component.

ACTIVE COMPARATOR

The doses of NY-ESO-1 and Montanide will remain the same as in Phase I; the highest tolerated Phase I dose of Poly-ICLC will become the Phase II Poly-ICLC dose. In Phase II, patients will be randomized to a subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD (Arm A) or with NY-ESO-1 protein, Poly-ICLC dose TBD and Montanide (Arm B).

Biological: NY-ESO-1 protein; Poly-ICLC; Montanide

Interventions

NY-ESO-1 protein; Poly-ICLC; Montanide BIOLOGICAL

Phase I represents the dose-escalation component with Poly-ICLC given in combination with NY-ESO-1 and Montanide in an open-label fashion. The dose of Poly-ICLC will be increased stepwise from 0.35mg to 1.4mg while the dose of NY-ESO-1 antigen (100µg) and Montanide (1.1mL) will be held constant. Phase II: The doses of NY-ESO-1 and Montanide will remain the same as in Phase I; the highest tolerated Phase I dose of Poly-ICLC will become the Phase II Poly-ICLC dose. In Phase II, patients will be randomized to a subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD (Arm A) or with NY-ESO-1 protein, Poly-ICLC dose TBD and Montanide (Arm B).

Also known as: Cancer-Testis (CT) antigen expression: NY-ESO-1, Poly ICLC: carboxymethylcellulose, polyinosinic-polycytidylic acid & poly-L-lysine double-stranded RNA, Montanide® ISA-51 VG: mineral oil-based adjuvant; also called (IFA)incomplete Freund's adjuvant.

Dose-escalation component; Phase II is the randomized component.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed cCr without clinical evidence of disease.
• 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 \[67\].
• Life expectancy \> 6 months.
• Age \> 18 years.
• Able and willing to give written informed consent for participation in the trial (see Section 12.2).

You may not qualify if:

• 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 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.
• Prior chemotherapy or vaccine therapy.
• Radiation therapy, biological therapy or surgery within 4 weeks prior to first dose of study agent.
• Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted.
• 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.
• 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.
• Children \<18 years of age who cannot undergo the leukapheresis procedure, do not meet the disease staging and/or the size criteria for frequent blood donations

Sponsors & Collaborators

• Nina Bhardwaj: lead
• Ludwig Institute for Cancer Research: collaborator
• Oncovir, Inc.: collaborator
• Cancer Research Institute, New York City: collaborator

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Related Links

• Click here for more information about this study: Poly-ICLC as an adjuvant for NY-ESO-1 protein vaccination with or without Montanide ® ISA-51 VG in patients with high risk melanoma in complete clinical remission

MeSH Terms

Conditions

Melanoma; Skin Neoplasms; Carcinogenesis; Neoplasms

Interventions

poly ICLC; Monatide (IMS 3015); Poly I-C

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Poly C; Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Poly I

Results Point of Contact

• Title: Dr. Nina Bhardwaj
• Organization: Icahn School of Medicine at Mount Sinai

nina.bhardwaj@mssm.edu

212-824-8427

Study Officials

• Nina Bhardwaj, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Anna Pavlick, D.O.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Tumor Vaccine Program

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: September 1, 2010
• Primary Completion: March 11, 2013
• Study Completion: March 11, 2013
• Last Updated: February 13, 2018
• Results First Posted: February 13, 2018

Record last verified: 2017-11

Locations

US (1)