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

Phase 2

Completed

• Conditions: Malignant Melanoma
• Interventions: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg; Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg; Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg; Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg; Drug: Dacarbazine + Interferon alpha

• Registration Number: NCT00911443
• Lead Sponsor: sigma-tau i.f.r. S.p.A.

Brief 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 \<= 0.05 vs the alternative hypothesis that P1 \>= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-02-26
• Results First Submitted: 2009-02-26
• Study First Submitted QC: 2009-04-07
• Results First Submitted QC: 2009-04-07
• Study First Posted: 2009-06-02
• Results First Posted: 2009-06-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-01
• Last Update Posted: 2009-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg	Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg	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 mg	Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg	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 mg	Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg	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 mg	Dacarbazine + Thymosin-alpha-1 3.2 mg	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 alpha	Dacarbazine + Interferon alpha	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.

Primary Outcome Measures

Name	Time	Method
Overall Tumor Response	1 year	Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years	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.
Progression Free Survival	2 years	Progression Free Survival is defined as the time from the randomization to progression or death

Trial Locations

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

Klinik fur Dermatologie und Allergologie der RWTH Aachen; 🇩🇪 Aachen, Germany

Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte; 🇩🇪 Berlin, Germany

Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie; 🇩🇪 Buxtehude, Germany

Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat; 🇩🇪 Frankfurt, Germany

Klinikum Hannover, Hautklinik Linden; 🇩🇪 Hannover, Germany

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