Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma

sigma-tau i.f.r. S.p.A.488 enrolled

Overview

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%).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

488

Conditions

Malignant Melanoma

Interventions

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.

Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mgBIOLOGICAL

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.

Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mgBIOLOGICAL

Dacarbazine 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 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.

Dacarbazine + Thymosin-alpha-1 3.2 mgBIOLOGICAL

Dacarbazine 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.

Dacarbazine + Interferon alphaDRUG

Dacarbazine 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (64)

CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

La Tronche, France

CHU de Limoges Hopital Dupuytren Service de Dermatologie

Limoges, France

Hopital Saint-Eloi Service de Dermatologie

Montpellier, France

Centre Eugene Marquis Departement d'Oncologie Medicale

Rennes, France

Hopital Purpan Service de Dermatologie

Toulouse, France

Outcomes

Primary Outcomes

Overall Tumor Response

Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response

Time frame: 1 year

Secondary Outcomes

Overall Survival

The 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.

Time frame: 2 years

Progression Free Survival

Progression Free Survival is defined as the time from the randomization to progression or death

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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