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A Phase Ia/Ib Study of a DNA Vaccine in Patients with Stage IIB-IV Malignant Melanoma
[Protocol 07-003]
- Full Title :
- A PHASE IA/IB STUDY OF THE SAFETY AND IMMUNOGENICITY OF A XENOGENEIC TYROSINASE DNA VACCINE ADMINISTERED BY IN VIVO ELECTROPORATION IN PATIENTS WITH AJCC STAGE IIB-IV MALIGNANT MELANOMA
- Purpose :
This study is evaluating the safety and effectiveness of a DNA vaccine given in a new way to patients with stage IIB-IV melanoma. The vaccine in this trial contains DNA (genetic material) from mouse tyrosinase, one of many proteins found in both melanoma cells and normal skin cells. The vaccine was designed to teach the immune system that cells containing tyrosinase may be harmful. There is no evidence yet that injection of tyrosinase DNA protects against melanoma.
Researchers have already completed one study where they injected mouse tyrosinase DNA into patients with melanoma using a regular injection method. The purpose of this study is to assess a new way of administering melanoma vaccines called "electroporation," to see if changes in the way vaccines are made and given can make vaccines more effective.
Electroporation uses a device that injects substances into muscle along with small amounts of electricity. This approach has been shown to be more effective than regular injection needles and safe when evaluated in animals. Devices similar to this have been used in many studies to deliver chemotherapy directly into patients' tumors.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of stage IIB, IIC, III, or IV melanoma.
- At least 4 weeks must have passed since completion of any prior therapies, and patients must have recovered from all side effects.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Jedd Wolchok at 646-888-2395 or Dr. Paul Chapman at 646-888-2378.
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