Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines

September 15, 2011 updated by: Memorial Sloan Kettering Cancer Center

Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines: A Phase I Trial to Assess Safety and Immune Response

The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV. Patients free of disease after surgical resection will also be eligible.
  • For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
  • Patients must be HLA-A0201 positive.
  • Patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent.
  • Patients must have a Karnofsky performance status of at least 80.
  • LDH < than or = to 2x upper limit of normal value; albumin > than or = to 3.5 mg/dl.
  • A CBC prior to vaccination with WBC > or = to 3000, platelets > or = to 100,000.
  • Patients must be free of detectable brain metastases.

Exclusion Criteria:

  • Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. Patients must be fully recovered from any previous therapy or surgery.
  • Patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase.
  • Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
  • Patients who have preexisting retinal or choroidal eye disease will be excluded.
  • Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
  • Pregnant women or women who are less than 3 months post-partum are not eligible. Women who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative BHCG within 2 weeks of vaccination) nor be nursing during treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Patients will get human tyrosinase vaccination.
Biological: human tyrosinase
Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
EXPERIMENTAL: 2
Patient will get mouse tyrosinase DNA vaccination.
Biological: mouse tyrosinase
Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.
Time Frame: conclusion of the study
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.
Time Frame: conclusion of the study
conclusion of the study
Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.
Time Frame: conclusion of the study
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (ESTIMATE)

June 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 15, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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