Trial Outcomes & Findings for Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma (NCT NCT00885534)
NCT ID: NCT00885534
Last Updated: 2015-05-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
2 years
Results posted on
2015-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Patient deemed ineligible
|
1
|
Baseline Characteristics
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Cisplatin, Vinblastine, Temozolomide
n=7 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPer 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
Outcome measures
| Measure |
Cisplatin, Vinblastine, Temozolomide
n=6 Participants
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.
|
|---|---|
|
Overall Response to CVT Chemotherapy.
Partial Response
|
1 participants
|
|
Overall Response to CVT Chemotherapy.
Stable Disease
|
5 participants
|
Adverse Events
Cisplatin, Vinblastine, Temozolomide
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cisplatin, Vinblastine, Temozolomide
n=6 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 2
|
|
General disorders
Dehydration
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Cisplatin, Vinblastine, Temozolomide
n=6 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Creatinine increased
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
2/6 • Number of events 2
|
|
Renal and urinary disorders
Urogenital disorder
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fever (in the absence of neutropenia)
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Glucose, high (hyperglycemia)
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Bilirubin (hyperbilirubinemia)
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
INR increased
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
16.7%
1/6 • Number of events 1
|
Additional Information
Dr. Paul Chapman
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place