Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Schering-Plough
In this Phase II trial, chemotherapy-naïve patients with palpable Stage III or Stage IV M1a melanoma scheduled to undergo surgical resection will be treated with TMZ in 8 week cycles according to the extended dosing schedule of 75mg/m2/day x 6 weeks with 2 weeks off. Patients will be treated until maximal response to TMZ and then undergo resection of residual disease. The primary endpoint will be tumor response as measured by the RECIST criteria. Patients will be seen monthly.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Palpable Stage III (N1b, N2b, N2c, or N3) or Stage IV (M1a) cutaneous melanoma. Patient must be a potential candidate for complete surgical resection.
Age ≥ 18 years
Histologic proof of pathology reviewed and confirmed at MSKCC
Measurable disease by RECIST criteria
Determination of surgical resectability by surgeon at MSKCC
No prior chemotherapy for melanoma. Prior interferon, interleukin-2 or vaccine therapy is allowed.
No other concurrent chemotherapy, immunotherapy, or radiotherapy
Karnofsky performance status ≥60
Adequate organ function
You may not be if
Uveal or mucosal melanoma
Patients with melanoma deemed not amenable to surgical resection or who are not surgical candidates for medical reasons
Frequent vomiting or medical conditions that could interfere with oral medication intake
Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy
Pregnancy or nursing
History of HIV infection even if on HAART as TMZ leads to CD4+ T cell leukopenia
Concurrent use of high dose vitamins and herbs
Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy
Clareo Health | Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection
