Trial Outcomes & Findings for Biochemotherapy With Temozolomide for Metastatic Melanoma (NCT NCT00505635)
NCT ID: NCT00505635
Last Updated: 2020-09-24
Results Overview
TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
TERMINATED
PHASE2
5 participants
Following two 21 day cycles until disease progression
2020-09-24
Participant Flow
Recruitment Period: March 14, 2007 through July 9, 2009. All participants recruited at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Biochemotherapy With Temozolomide
Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biochemotherapy With Temozolomide for Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Biochemotherapy With Temozolomide
n=5 Participants
Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
|
|---|---|
|
Age, Continuous
|
43 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Following two 21 day cycles until disease progressionTTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Outcome measures
| Measure |
Biochemotherapy With Temozolomide
n=5 Participants
Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
|
|---|---|
|
Time to Progression (TTP)
|
93.2 days
Interval 44.0 to 164.0
|
SECONDARY outcome
Timeframe: Following each 21 day cyclesResponse evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
Outcome data not reported
Adverse Events
Biochemotherapy With Temozolomide
Serious adverse events
| Measure |
Biochemotherapy With Temozolomide
n=5 participants at risk
Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
|
|---|---|
|
General disorders
Fatigue
|
80.0%
4/5 • 1 year and 7 months
|
|
Infections and infestations
Fever/rigor
|
20.0%
1/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
5/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
3/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin Level
|
20.0%
1/5 • 1 year and 7 months
|
Other adverse events
| Measure |
Biochemotherapy With Temozolomide
n=5 participants at risk
Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
|
|---|---|
|
General disorders
Fatigue
|
100.0%
5/5 • 1 year and 7 months
|
|
Gastrointestinal disorders
Anorexia
|
80.0%
4/5 • 1 year and 7 months
|
|
Infections and infestations
Fever/rigor
|
100.0%
5/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Hypotension
|
80.0%
4/5 • 1 year and 7 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • 1 year and 7 months
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • 1 year and 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
4/5 • 1 year and 7 months
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
60.0%
3/5 • 1 year and 7 months
|
|
Nervous system disorders
Peripheral Neuropathy
|
20.0%
1/5 • 1 year and 7 months
|
|
Vascular disorders
Fluid retention
|
100.0%
5/5 • 1 year and 7 months
|
|
Renal and urinary disorders
Renal dysfunction (Creatinine)
|
60.0%
3/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
100.0%
5/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
2/5 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin Level
|
80.0%
4/5 • 1 year and 7 months
|
Additional Information
Nicholas E. Papadopoulos, MD / Professor
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place