Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Skin Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2005 |
| End Date: | March 2009 |
In this study, we want to find out how likely it is for temozolomide to shrink melanoma
tumors that have spread only to areas that could be removed by surgery. We also want to
study the melanoma before and after temozolomide treatment to learn why some tumors respond
and others do not. This is a Phase II trial. This means that it will test a drug - in this
case, temozolomide -- that has already been studied and shown to be safe.
Surgery, when possible, is the main treatment for patients with melanoma like yours. In most
people, however, melanoma cells have already spread to other places in the body. This means
that even with surgery, many people will have the melanoma come back. This is often fatal.
One goal of this trial is to treat the melanoma cells that might have spread before they
have a chance to grow.
As part of this trial, we also study which genes are turned on and which genes are turned
off in your tumor. We will obtain tumor from the biopsy done before you started temozolomide
treatment and from the tumor removed during the surgery done after you finish temozolomide
treatment. This may help us understand how temozolomide works and how to recognize which
tumors will respond.
Before and during the temozolomide treatment, we will also test a new way of measuring the
amount of tumor present. This involves a special way of analyzing the CT scan which you will
have anyway. This new technique may allow us to see tumor shrinkage very early in the
treatment course.
tumors that have spread only to areas that could be removed by surgery. We also want to
study the melanoma before and after temozolomide treatment to learn why some tumors respond
and others do not. This is a Phase II trial. This means that it will test a drug - in this
case, temozolomide -- that has already been studied and shown to be safe.
Surgery, when possible, is the main treatment for patients with melanoma like yours. In most
people, however, melanoma cells have already spread to other places in the body. This means
that even with surgery, many people will have the melanoma come back. This is often fatal.
One goal of this trial is to treat the melanoma cells that might have spread before they
have a chance to grow.
As part of this trial, we also study which genes are turned on and which genes are turned
off in your tumor. We will obtain tumor from the biopsy done before you started temozolomide
treatment and from the tumor removed during the surgery done after you finish temozolomide
treatment. This may help us understand how temozolomide works and how to recognize which
tumors will respond.
Before and during the temozolomide treatment, we will also test a new way of measuring the
amount of tumor present. This involves a special way of analyzing the CT scan which you will
have anyway. This new technique may allow us to see tumor shrinkage very early in the
treatment course.
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.
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
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
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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