Phase 2 N=488 Randomized Treatment

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

Malignant Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT00911443 ↗

Enrolled (actual)

488

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Overall Tumor Response — 7; 10; 6; 12 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 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 (Biological); Dacarbazine + Interferon alpha (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: sigma-tau i.f.r. S.p.A.
Primary completion: Sep 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Tumor Response	7; 10; 6; 12; 4	—
SECONDARY Overall Survival	9.3; 8.6; 10.3; 9.3; 6.6	—
SECONDARY Progression Free Survival	1.9; 1.8; 1.8; 2.0; 1.8	—

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. 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 = 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).

Eligibility Criteria

Inclusion Criteria

Have read and signed the informed consent form
18 years = 1 measurable lesion
Adequate renal function as demonstrated by serum creatinine level = 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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Data sourced from ClinicalTrials.gov (NCT00911443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.