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

Primary Purpose

Melanoma, Skin

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

human tyrosinase

mouse tyrosinase

About this trial

This is an interventional treatment trial for Melanoma focused on measuring DNA, HU & MOUSE, TYROSINASE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Patients will get human tyrosinase vaccination.

Patient will get mouse tyrosinase DNA vaccination.

Outcomes

Primary Outcome Measures

Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.

Secondary Outcome Measures

To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.

Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.

Full Information

NCT ID

NCT00698100

First Posted

June 12, 2008

Last Updated

September 15, 2011

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT00698100

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Skin

Keywords

DNA, HU & MOUSE, TYROSINASE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients will get human tyrosinase vaccination.

Arm Title

Arm Type

Experimental

Arm Description

Patient will get mouse tyrosinase DNA vaccination.

Intervention Type

Biological

Intervention Name(s)

human tyrosinase

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

mouse tyrosinase

Intervention Description

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.

Time Frame

conclusion of the study

Title

Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.

Time Frame

conclusion of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jedd Wolchok, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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