Clinical trial · Interventional
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in Patients With Advanced -Stage Metastatic Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 \<= 0.05 vs the alternative hypothesis that P1 \>= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine + Interferon alpha | Drug | — | UNRESOLVED |
| Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg | Biological | — | UNRESOLVED |
| Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg | Biological | — | UNRESOLVED |
| Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg | Biological | — | UNRESOLVED |
| Dacarbazine + Thymosin-alpha-1 3.2 mg | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg
- description
- Dacarbazine 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.
- interventionNames
- Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
- type
- EXPERIMENTAL
- label
- Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
- description
- Dacarbazine 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.
- interventionNames
- Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/deciliter (dl) * Absolute Neutrophil Count (ANC) \>= 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
References
Publications (0)
Data not yet available