Status:
COMPLETED
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Lead Sponsor:
sigma-tau i.f.r. S.p.A.
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00911443
Start Date
July 1 2002
End Date
September 1 2007
Last Update
July 9 2009
Active Locations (64)
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1
CHU de Grenoble Hopital Albert Michallon Service de Dermatologie
La Tronche, France, 38043
2
CHU de Limoges Hopital Dupuytren Service de Dermatologie
Limoges, France, 87042
3
Hopital Saint-Eloi Service de Dermatologie
Montpellier, France, 34295
4
Centre Eugene Marquis Departement d'Oncologie Medicale
Rennes, France, 35042