AzTrials
AzTrials

Malignant MelanomaPhase 2NCT00911443

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

A Phase 2 study testing Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg and Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg in people with Malignant Melanoma, run by sigma-tau i.f.r. S.p.A. at 64 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Melanoma
What is being tested?
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg and Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
64 sitesin 8 countries
Study dates
Jul 2002to Sep 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

64 sites in 8 countries.

64 sites in 8 countries

Italy25 sites

  • ASL 1 Servizio di Oncologia

    Agrigento

  • UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe

    Albano Laziale, ROMA, 00041

  • Azienda Ospedaliera S. Elia, UO di Oncologia

    Caltanissetta, 93100

  • Azienda Ospedaliera Garibaldi, UO Oncologia Medica

    Catania, 95126

  • Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica

    Chieti, 66100

  • Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia

    Enna, 94100

  • Università di Firenze Dipartimento di Scienze Dermatologiche

    Florence, 50121

  • Ospedale Pierantoni, Divisione Oncologia Medica

    Forlì, 47100

  • Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1

    Genova, 16132

  • Istituto Europeo di Oncologia, Divisione di Chirurgia Generale

    Milan, 20141

  • Casa di Cura San Pio X, UO Oncologia Medica

    Milan, 20159

  • Ospedale PF Calvi Dipartimento di Oncologia

    Noale, VENEZIA, 30033

  • Ospedale Civile, UO di Oncologia

    Ragusa, 97100

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica

    Reggio Calabria, 89100

  • Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia

    Roma, 00133

  • IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A

    Roma, 00144

  • Ospedale Sandro Pertini, Oncologia Medica

    Roma, 00157

  • Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva

    Roma, 00161

  • Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia

    Roma, 00167

  • Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia

    Siena, 53100

  • U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"

    Siena, 53100

  • Ospedale SS Trinità Oncologia

    Sora, FROSINONE, 03039

  • Ospedale Umberto I°, Divisione di Oncologia Medica

    Syracuse, 96100

  • Ospedale San Vincenzo U.O. Oncologia Medica

    Taormina, MESSINA, 98039

  • Ospedale Bel Colle UO di Oncologia

    Viterbo, 01100

Other trials in Italy

Spain9 sites

  • Hosp. Clinic i Provincial Servicio de Oncologia

    Barcelona, 08036

  • Hosp. Universitario de Jaen Servicio de Oncologia

    Jaén, 23007

  • Instituto Catalan Oncologico, Servicio de Oncologia

    L'Hospitalet de Llobregat, BARCELONA, 08907

  • Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano

    Madrid, 28040

  • Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos

    Málaga, 29010

  • Hosp. Univ. de Canarias Servicio de Oncologia Medica

    San Cristóbal de La Laguna, SANTA CRUZ DE TENERIFE, 38320

  • Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico

    Seville, 41013

  • Instituto Valenciano Oncologico

    Valencia, 46009

  • Hospital General Universitario de Valencia Unidad de Oncologia Medica

    Valencia, 46014

Other trials in Spain

Germany8 sites

  • Klinik fur Dermatologie und Allergologie der RWTH Aachen

    Aachen, 52074

  • Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte

    Berlin, 10117

  • Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie

    Buxtehude, 21614

  • Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat

    Frankfurt, 60590

  • Klinikum Hannover, Hautklinik Linden

    Hanover, D-30449

  • Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel

    Kiel, 24105

  • Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg

    Magdeburg, 39120

  • Dermatologische Klinik der Universitat Tubingen

    Tübingen, 72076

Other trials in Germany

Poland8 sites

  • Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna

    Gdansk, 80-211

  • Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii

    Krakow, 31-115

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej

    Lodz, 93-509

  • Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej

    Lublin, 20-081

  • Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM

    Poznan, 61-868

  • Oddzial Chemioterapii

    Szczecin, 71-730

  • Klinika Onkologii Centralnego Szpitala WAM

    Warsaw

  • Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 53-439

Other trials in Poland

Hungary6 sites

  • Orszagos Bor-es Nemikortani Intezet

    Budapest, H-1085

  • Orszagos Onkologiai Intezet Borgyogyaszat

    Budapest, H-1122

  • Petz Aladar Megyei Korhaz, Borgyogyaszat

    Győr, H-9024

  • Miskolc Megyei Korhaz Borgyogyaszat

    Miskolc, H-3501

  • Pecsi Egyetem Borgyogyaszati Klinika

    Pécs, H-7600

  • Szegedi Egyetem Borgyogyaszati Klinika

    Szeged, H-6701

Other trials in Hungary

France5 sites

  • CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

    La Tronche, 38043

  • CHU de Limoges Hopital Dupuytren Service de Dermatologie

    Limoges, 87042

  • Hopital Saint-Eloi Service de Dermatologie

    Montpellier, 34295

  • Centre Eugene Marquis Departement d'Oncologie Medicale

    Rennes, 35042

  • Hopital Purpan Service de Dermatologie

    Toulouse, 31059

Other trials in France

Portugal2 sites

  • Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C

    Lisbon, 1099-023

  • Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3

    Porto, 4200

Other trials in Portugal

Switzerland1 site

  • Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau

    Aarau, CH-5001

Other trials in Switzerland

About this study

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

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%).

Being tested
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg, Dacarbazine + Thymosin-alpha-1 3.2 mg, Dacarbazine + Interferon alpha
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mgBiological

    Also called Zadaxin, Thymalfasin, ST1472, Deticene

    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

    Also called Zadaxin, Thymalfasin, ST1472, Deticene

    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

    Also called Zadaxin, Thymalfasin, ST1472, Deticene

    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

    Also called Zadaxin, Thymalfasin, ST1472, Deticene

    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

    Also called Deticene, Roferon

    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.

Study groups in NCT00911443
Study groupRoleWhat they receive
Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mgExperimentalDacarbazine 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.
Receives: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mgExperimentalDacarbazine 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.
Receives: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mgExperimentalDacarbazine 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.
Receives: Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine + Thymosin-alpha-1 3.2 mgExperimentalDacarbazine 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.
Receives: Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine + Interferon alphaActive comparatorDacarbazine 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.
Receives: Drug: Dacarbazine + Interferon alpha

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Tumor Response

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

    Measured: 1 year

Secondary outcomes (2)

  1. 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.

    Measured: 2 years

  2. Progression Free Survival

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2009 (estimated)
  2. Study startJul 2002
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911443
Sponsor's protocol ID
ST1472DM01012
Status last verified
Jul 2009
First submitted
26 Feb 2009
Last updated
9 Jul 2009
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg and Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg in people with Malignant Melanoma, run by sigma-tau i.f.r. S.p.A. at 64 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Italy, Spain, Germany, Poland, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Tumor Response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2009.

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