NCT01100528

Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance

Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal melanoma. PURPOSE: This phase II trial is studying how well giving dacarbazine together with recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with genetic imbalance.

Detailed description

PRIMARY OBJECTIVES: I. Assess disease-free survival (DFS) with sequential dacarbazine and interferon-alfa-2b as an adjuvant to primary therapy for patients with uveal melanoma with genetic imbalance. SECONDARY OBJECTIVES: I. Evaluate side effects and assess safety in the patient population. II. Examine the relationship between the levels of plasma biomarkers of immune function and tumor invasion and the clinical outcome. OUTLINE: Patients receive dacarbazine IV on days 1 and 29. Beginning 4 weeks after the second dose of dacarbazine, patients receive recombinant interferon alfa-2b subcutaneously 3 times a week for 24 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Ciliary Body and Choroid Melanoma, Small Size
• Iris Melanoma
• Recurrent Intraocular Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant interferon alfa-2b	Given subcutaneously (SC) 3 times a week for 24 weeks
DRUG	dacarbazine	Given IV on days 1 and 29
OTHER	laboratory biomarker analysis	Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Timeline

• Start date: 2009-11-11
• Primary completion: 2015-07-25
• Completion: 2017-12-14
• First posted: 2010-04-09
• Last updated: 2019-02-26
• Results posted: 2018-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study