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

Purpose

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.

Condition	Intervention	Phase
Melanoma Skin	Biological: human tyrosinase Biological: mouse tyrosinase	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Deoxyribonucleic acid

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	June 2002
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698100

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jedd Wolchok, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00698100 History of Changes
Other Study ID Numbers:	99-122
Study First Received:	June 12, 2008
Last Updated:	September 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

DNA
HU & MOUSE
TYROSINASE

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 16, 2013