Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
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|ClinicalTrials.gov Identifier: NCT01100528|
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : October 29, 2018
Last Update Posted : February 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Ciliary Body and Choroid Melanoma, Medium/Large Size Ciliary Body and Choroid Melanoma, Small Size Iris Melanoma Recurrent Intraocular Melanoma||Biological: recombinant interferon alfa-2b Drug: dacarbazine Other: laboratory biomarker analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance|
|Actual Study Start Date :||November 11, 2009|
|Actual Primary Completion Date :||July 25, 2015|
|Actual Study Completion Date :||December 14, 2017|
Experimental: Arm I
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.
Biological: recombinant interferon alfa-2b
Given subcutaneously (SC) 3 times a week for 24 weeks
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
- Number of Patients With Disease-free Survival (DFS) [ Time Frame: 5 years from time-of-enrollment ]DFS will be calculated from the date treatment starts to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier. Treatment will be considered relatively ineffective in this population if the underlying 2-year DFS is <60%, whereas the combination will be considered promising if the underlying rate is >80%.
- Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0 [ Time Frame: up to 32 weeks from start of study ]Number of participants with toxicity as defined as an underlying risk of >33% Grade 3 (non blood/bone marrow) or Grade 4 adverse events that are related to therapy, assessed by NCI CTCAE version 3.0
- Changes in Plasma Biomarkers and Their Association With DFS [ Time Frame: 5 yrs from start of treatment ]Plasma levels of these markers will be summarized at baseline and over time quantitatively and graphically. Specific regulators of immune escape and tumor cell invasion identified in uveal melanoma gene array studies will be measured. Peripheral blood cells and plasma will be analyzed for granulysin (a measure of natural killer cells (NK) activity), beta2-microglobulin, autotoxin, lysophosphatidic acid (a product of autotaxin), matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100528
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Yogen Saunthararajah, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|