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A Phase II Study of Imatinib in Patients with Inoperable Stage III or IV Melanoma with Alterations in the C-KIT Protein
[Protocol 07-014]
- Full Title :
- A PHASE II STUDY OF IMATINIB MESYLATE (STI571; NSC #716051; IND 61135)IN PATIENTS WITH INOPERABLE AJCC STAGE III OR IV MELANOMA HARBORING SOMATIC ALTERATIONS OF C-KIT (NCI # 7754)
- Purpose :
Cancers are caused by changes in proteins inside cells. These changes make cells grow out of control. c-KIT is a protein that, if changed, can cause some kinds of cancer. The drug imatinib (Gleevec®) blocks many proteins, including c-KIT. Imatinib is approved for the treatment of some cancers caused by c-KIT (including chronic myelogenous leukemia and a rare cancer called GIST). It is not approved for the treatment of melanoma.
Melanomas that start on the palms of the hands and the soles of the feet; on the slippery skin inside the body (mucosa), such as that in the sinuses, nose, mouth, stomach, intestines, and female reproductive organs; and on skin that has been very damaged by the sun often have changes in the c-KIT protein. The purpose of this study is to study changes in c-KIT and the effectiveness of imatinib in patients with melanoma that has spread or cannot be cured with surgery, and which began on a part of the body that may make it treatable with imatinib.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage III or IV melanoma that began on sun-damaged skin or on mucosal tissues.
- Patients may have had up to one prior regimen of chemotherapy for metastatic disease and may have had radiation therapy. At least 2 weeks must have passed since completion of prior therapy and entry into the study, and patients must have recovered from any side effects.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Gary K. Schwartz at 212-639-8324 or Dr. Paul Chapman at 212-639-5015.
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