Trial Outcomes & Findings for Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma (NCT NCT00911443)
NCT ID: NCT00911443
Last Updated: 2009-07-09
Results Overview
Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
488 participants
Primary outcome timeframe
1 year
Results posted on
2009-07-09
Participant Flow
Recruitment started on August 2002 and has been completed on January 2006. All patients were recruited at medical clinic facilities (Oncology/Dermatology departments)
Only patients who did not meet the entry selection criteria were excluded from study entry.
Participant milestones
| Measure |
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Thymosin-alpha-1 3.2 mg
Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
97
|
98
|
99
|
97
|
|
Overall Study
COMPLETED
|
97
|
97
|
98
|
99
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg
n=98 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Thymosin-alpha-1 3.2 mg
n=99 Participants
Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
142.0 Participants
n=8 Participants
|
|
Age Continuous
|
54 years
STANDARD_DEVIATION 14 • n=5 Participants
|
54 years
STANDARD_DEVIATION 14 • n=7 Participants
|
56 years
STANDARD_DEVIATION 13 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11 • n=4 Participants
|
57 years
STANDARD_DEVIATION 12 • n=21 Participants
|
55 years
STANDARD_DEVIATION 13 • n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0.0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
346.0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
226.0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
262.0 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
43.0 participants
n=8 Participants
|
|
Region of Enrollment
Portugal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1.0 participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
19.0 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
13 participants
n=4 Participants
|
6 participants
n=21 Participants
|
27.0 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
32 participants
n=5 Participants
|
36 participants
n=4 Participants
|
37 participants
n=21 Participants
|
159.0 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
25 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
85.0 participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1.0 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
27 participants
n=5 Participants
|
31 participants
n=4 Participants
|
28 participants
n=21 Participants
|
153.0 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 1 yearTumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
Outcome measures
| Measure |
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg
n=98 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Thymosin-alpha-1 3.2 mg
n=99 Participants
Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|---|---|---|
|
Overall Tumor Response
|
7 participants
|
10 participants
|
6 participants
|
12 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 2 yearsThe survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored.
Outcome measures
| Measure |
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg
n=98 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Thymosin-alpha-1 3.2 mg
n=99 Participants
Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|---|---|---|
|
Overall Survival
|
9.3 months
Interval 8.0 to 11.1
|
8.6 months
Interval 6.1 to 11.6
|
10.3 months
Interval 8.2 to 12.7
|
9.3 months
Interval 6.7 to 11.7
|
6.6 months
Interval 5.3 to 9.9
|
SECONDARY outcome
Timeframe: 2 yearsProgression Free Survival is defined as the time from the randomization to progression or death
Outcome measures
| Measure |
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg
n=98 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Thymosin-alpha-1 3.2 mg
n=99 Participants
Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
Dacarbazin + Interferon Alpha
n=97 Participants
Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
|
|---|---|---|---|---|---|
|
Progression Free Survival
|
1.9 months
Interval 1.8 to 2.6
|
1.8 months
Interval 1.8 to 2.0
|
1.8 months
Interval 1.8 to 2.6
|
2.0 months
Interval 1.8 to 3.5
|
1.8 months
Interval 1.7 to 2.0
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60