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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00911443 (opens ClinicalTrials.gov in a new tab)Other idST1472DM01012
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
488 participants (actual)
Sponsor
sigma-tau i.f.r. S.p.A. · Industry
Design
Randomized · Open label (no masking)
Countries
8 countries

France, Germany, Hungary, Italy, Poland, Portugal, Spain, Switzerland

Start
Jul 2002
Primary completion
Sept 2007
Completion
Sept 2007
First posted
2 Jun 2009 (estimated)
Last update posted
9 Jul 2009 (estimated)
Conditions
Malignant Melanoma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200320042005200620072008
  1. Ph 2

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

    NCT00911443

    Jul 2002 to Sept 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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%).

Interventions

  • Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mgBiological
  • Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mgBiological
  • Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mgBiological
  • Dacarbazine + Thymosin-alpha-1 3.2 mgBiological
  • Dacarbazine + Interferon alphaDrug

Arms5

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall Tumor Response

    Time frame · 1 year

    Registry description

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

Secondary outcomes(2)

  1. Overall Survival

    Time frame · 2 years

    Registry description

    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.

  2. Progression Free Survival

    Time frame · 2 years

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 year

Overall Tumor Response

GroupValue (participants)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg7
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg10
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg6
Dacarbazin + Thymosin-alpha-1 3.2 mg12
Dacarbazin + Interferon Alpha4
Secondary and other outcome results(2)
Secondary outcomeMedian· 2 years

Overall Survival

GroupValue (months)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg9.3
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg8.6
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg10.3
Dacarbazin + Thymosin-alpha-1 3.2 mg9.3
Dacarbazin + Interferon Alpha6.6
Secondary outcomeMedian· 2 years

Progression Free Survival

GroupValue (months)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg1.9
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg1.8
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg1.8
Dacarbazin + Thymosin-alpha-1 3.2 mg2.0
Dacarbazin + Interferon Alpha1.8

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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