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Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Plain-language guide to NCT00911443: phase 2 randomized trial of Thymosin Alpha-1, 488 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00911443
- Phase
- phase 2
- Status
- completed
- Start
- 2002-07
- Completion (planned or actual)
- 2007-09
- Participants
- 488 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Malignant Melanoma
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Thymosin Alpha-1.
Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST).
Secondary end-points are Overall Survival and Progression Free Survival.
It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Dacarbazine + Interferon alpha (active comparator).
The registry classes the interventions as biological and drug.
Who Took Part
488 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have read and signed the informed consent form. 18 years \<=Age\<= 75 years. Adequate contraception practice (fertile female patient). Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases and \>= 1 measurable lesion. Absolute Neutrophil Count (ANC) \>= 1.5 x 10000000000/L ; platelets \>= 100 x 10000000000/Liter (L).
The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: clinical diagnosis of autoimmune disease; transplant recipient; pregnancy documented by a urine pregnancy test or lactation.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Thymosin Alpha-1 and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Thymosin Alpha-1 study did not mask who received what.
It started in 2002-07 with completion listed for 2007-09.
It ran at 64 sites in Italy (25), Spain (9), Germany (8), Poland (8), Hungary (6) and France (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Overall Tumor Response (time frame: 1 year).
It also tracked 2 secondary outcomes, for example Overall Survival and Progression Free Survival.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 488 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.