Phase 2
Completed N=488
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Source: ClinicalTrials.gov NCT00911443 ↗Enrolled (actual)
488
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Overall Tumor Response — 7; 10; 6; 12 participants
Summary
The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.
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.
Ninety-five patients are allocated to each arm to test the hypothesis that P0 = 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Tumor Response |
7; 10; 6; 12; 4 | — |
| SECONDARY Overall Survival |
9.3; 8.6; 10.3; 9.3; 6.6 | — |
| SECONDARY Progression Free Survival |
1.9; 1.8; 1.8; 2.0; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Have read and signed the informed consent form
- 18 years = 1 measurable lesion
- Adequate renal function as demonstrated by serum creatinine level = 1.5 x 10000000000/L ; platelets >= 100 x 10000000000/Liter (L)
- Good performance status: PS <= 1 (ZUBROD-ECOG-WHO scale)
- At least 12 week life expectancy
Exclusion Criteria
- Clinical diagnosis of autoimmune disease
- Transplant recipient
- Pregnancy documented by a urine pregnancy test or lactation
- Previous treatment with thymosin alpha 1
- Previous treatment with chemotherapy
- Presence of Central Nervous System (CNS) metastases
- Concomitant or prior history of malignancy other than melanoma
- Participation in another investigational trial within 30 days of study entry
- Active infectious process that is not of self-limiting nature
Data sourced from ClinicalTrials.gov (NCT00911443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.