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

This study has been completed.
Sponsor:
Information provided by:
sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:
NCT00911443
First received: February 26, 2009
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

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%).


Condition Intervention Phase
Malignant Melanoma
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: July 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
Active Comparator: 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.
Drug: 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.
Other Names:
  • Deticene
  • Roferon

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911443

  Show 64 Study Locations
Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
Investigators
Principal Investigator: Virginia Ferraresi, MD IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
Study Director: Roberto Camerini, MD Sigma-Tau SpA
  More Information

No publications provided

Responsible Party: ROBERTO CAMERINI / Head of Clinical Research II, sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier: NCT00911443     History of Changes
Other Study ID Numbers: ST1472DM01012
Study First Received: February 26, 2009
Results First Received: February 26, 2009
Last Updated: July 1, 2009
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
France: Institutional Ethical Committee
Spain: Ethics Committee
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Switzerland: Swissmedic
Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Thymalfasin
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 16, 2014