Melanoma, Skin Cancer
Conditions
Keywords
skin cancer, CISPLATIN, TEMOZOLOMIDE, VINBLASTINE, 09-017
Brief summary
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.
Interventions
DRUGCisplatin, Vinblastine, Temozolomide
Patients will receive CVT chemotherapy which consists of the following: Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Histologic proof of melanoma reviewed and confirmed at MSKCC * Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible. * Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate. * No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed. * No other concurrent chemotherapy, immunotherapy, or radiotherapy * ECOG performance status ≤ 1 * Adequate organ function defined as follows: ANC \>1500/mm3, Platelets \>130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft & Gault). * Adequate cardiac function to tolerate the hydration needed for cisplatin administration.
Exclusion criteria
* History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months. * Uveal melanoma primary * Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease. * 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. * History of HIV infection even if on HAART * Immunosuppressive drugs * High dose vitamins and herbs * Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response to CVT Chemotherapy. | 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cisplatin, Vinblastine, Temozolomide Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient deemed ineligible | 1 |
Baseline characteristics
| Characteristic | Cisplatin, Vinblastine, Temozolomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
Primary
Overall Response to CVT Chemotherapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cisplatin, Vinblastine, Temozolomide | Overall Response to CVT Chemotherapy. | Partial Response | 1 participants |
| Cisplatin, Vinblastine, Temozolomide | Overall Response to CVT Chemotherapy. | Stable Disease | 5 participants |