Trial Outcomes & Findings for Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection (NCT NCT00588341)
NCT ID: NCT00588341
Last Updated: 2016-02-01
Results Overview
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
COMPLETED
PHASE2
24 participants
2 years
2016-02-01
Participant Flow
Participant milestones
| Measure |
Treatment
Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment
Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Not treated due to metastatic disease
|
1
|
|
Overall Study
Patient ineligible
|
1
|
Baseline Characteristics
Phase II Trial of Neoadjuvant Temozolomide in Melanoma Patients With Palpable Stage III or IV Disease Undergoing Complete Surgical Resection
Baseline characteristics by cohort
| Measure |
Treatment
n=24 Participants
Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe 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
Outcome measures
| Measure |
Treatment
n=19 Participants
Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
|
|---|---|
|
Overall Objective Response (Complete Response or Partial Response)
Complete Response (CR)
|
2 participants
|
|
Overall Objective Response (Complete Response or Partial Response)
Partial Response (PR)
|
2 participants
|
|
Overall Objective Response (Complete Response or Partial Response)
Non Responder
|
15 participants
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=24 participants at risk
Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
|
|---|---|
|
General disorders
Fatigue
|
91.7%
22/24 • Number of events 22
|
|
Gastrointestinal disorders
Nausea
|
91.7%
22/24 • Number of events 22
|
|
Gastrointestinal disorders
Vomiting
|
91.7%
22/24 • Number of events 22
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
16.7%
4/24 • Number of events 4
|
Additional Information
Dr. Paul Chapman
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place