A Phase 2 interventional study of Temozolomide in Melanoma, Skin Cancer and Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 24 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Temozolomide
At the start of the trial a core needle biopsy of a palpable tumor will be obtained percutaneously in the office after administration of local anesthesia. Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks. After each cycle, patients will be re-evaluated for response. Responding patients will be offered another cycle of treatment. Patients will be treated until best response, progression of disease, or 6 cycles, whichever comes first. After completing temozolomide treatment, patients will be evaluated for surgical resection. It is expected that, unless there is progression of disease, patients will undergo resection (i.e. therapeutic lymph node dissection). In patients who have a complete clinical response to temozolomide, whether or not to do a subsequent lymph node dissection will be left up to the discretion of the surgeon and the patient.
Also known as: TMZ
Overall Objective Response (Complete Response or Partial Response)
The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response. Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease. Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement
Time frame: 2 years
| Milestone | Treatment |
|---|---|
| Started | 24 |
| Completed | 19 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Not treated due to metastatic disease | 1 |
| Withdrew: Patient ineligible | 1 |
The Response Evaluation Criteria in Solid Tumors (RECIST) will be used to determine treatment response. Clinical Complete Response (CRc) Disappearance of all target lesions and non-measurable disease. Pathological Complete Response (CRp) A CRc in which a lymph node dissection done after completing temozolomide treatment shows no pathological evidence of melanoma. Partial Response (PR) A greater or equal then 30% in the sum of the longest diameter of all target lesions relative to baseline measurement
| participants | Treatment |
|---|---|
| Complete Response (CR) | 2 |
| Partial Response (PR) | 2 |
| Non Responder | 15 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 0/24 (0%) | 22/24 (91.7%) |
| Event | Treatment |
|---|---|
| FatigueGeneral disorders | 22/24 |
| NauseaGastrointestinal disorders | 22/24 |
| VomitingGastrointestinal disorders | 22/24 |
| Glucose, high (hyperglycemia)Metabolism and nutrition disorders | 4/24 |
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 16 |
| Male | 8 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center