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Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection

Phase 2
18 Years
Not Enrolling
Melanoma, Skin Cancer, Cancer

Thank you

Trial Information

Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Serious infection requiring antibiotics, or nonmalignant medical illnesses that are
uncontrolled or whose control might be jeopardized by the complications of this

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall objective response rate (CR and PR)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Paul Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

March 2009

Related Keywords:

  • Melanoma
  • Skin Cancer
  • Cancer
  • Melanoma
  • Skin Cancer
  • Cancer
  • Temozolamide
  • TMZ
  • Skin Neoplasms
  • Melanoma



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021