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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
History of Changes

February 26, 2009
July 1, 2009
July 2002
September 2007   (final data collection date for primary outcome measure)
Overall Tumor Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911443 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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%).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
    Intervention: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
  • 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.
    Intervention: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
  • 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.
    Intervention: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
  • 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.
    Intervention: Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg
  • 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.
    Intervention: Drug: Dacarbazine + Interferon alpha
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary,   Italy,   Poland,   Portugal,   Spain,   Switzerland
 
NCT00911443
ST1472DM01012
No
ROBERTO CAMERINI / Head of Clinical Research II, sigma-tau i.f.r. S.p.A.
sigma-tau i.f.r. S.p.A.
Not Provided
Principal Investigator: Virginia Ferraresi, MD IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
Study Director: Roberto Camerini, MD Sigma-Tau SpA
sigma-tau i.f.r. S.p.A.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP