Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01100528
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : October 29, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ciliary Body and Choroid Melanoma, Medium/Large Size
Ciliary Body and Choroid Melanoma, Small Size
Iris Melanoma
Recurrent Intraocular Melanoma
Interventions Biological: recombinant interferon alfa-2b
Drug: dacarbazine
Other: laboratory biomarker analysis
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description

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.

recombinant interferon alfa-2b: Given subcutaneously (SC) 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Period Title: Overall Study
Started 38
Completed 35
Not Completed 3
Reason Not Completed
Death             1
Withdrawal by Subject             2
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description

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.

recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
All patients enrolled in study, regardless of treatment
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
20-29 years
2
   5.3%
30-39 years
2
   5.3%
40-49 years
3
   7.9%
50-59 years
16
  42.1%
60-69 years
9
  23.7%
70-79 years
6
  15.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
22
  57.9%
Male
16
  42.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
38
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
38
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
38
1.Primary Outcome
Title Number of Patients With Disease-free Survival (DFS)
Hide Description 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%.
Time Frame 5 years from time-of-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description:

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.

recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
8
  21.1%
2.Secondary Outcome
Title Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0
Hide Description 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
Time Frame up to 32 weeks from start of study
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled on study regardless of treatment
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description:

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.

recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.3%
3.Secondary Outcome
Title Changes in Plasma Biomarkers and Their Association With DFS
Hide Description 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.
Time Frame 5 yrs from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Information not collected
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description:

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.

recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame During treatment up to 32 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Hide Arm/Group Description

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.

recombinant interferon alfa-2b: Given SC 3 times a week for 24 weeks

dacarbazine: Given IV on days 1 and 29

laboratory biomarker analysis: Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up

All-Cause Mortality
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Affected / at Risk (%)
Total   10/38 (26.32%)    
Hide Serious Adverse Events
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Affected / at Risk (%) # Events
Total   2/38 (5.26%)    
Blood and lymphatic system disorders   
Coagulation - Other  1 [1]  1/38 (2.63%)  1
General disorders   
Constitutional Symptoms - Other  1  1/38 (2.63%)  1
1
Term from vocabulary, CTCAE V3.0
Indicates events were collected by systematic assessment
[1]
Pulmonary emboli to pulmonary arterial branches
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Affected / at Risk (%) # Events
Total   38/38 (100.00%)    
Blood and lymphatic system disorders   
Lymphocele  1  2/38 (5.26%)  2
Neutrophils/granulocytes (ANC/AGC)  1  7/38 (18.42%)  12
Lymphopenia  1  12/38 (31.58%)  26
Leukocytes (total WBC)  1  17/38 (44.74%)  37
Platelets  1  17/38 (44.74%)  23
Eye disorders   
Ocular/Visual - vision impaired  1  2/38 (5.26%)  2
Ophthalmoplegia/diplopia (double vision)  1  2/38 (5.26%)  2
Vision-flashing lights/floaters  1  3/38 (7.89%)  3
Gastrointestinal disorders   
Taste alteration (dysgeusia)  1  2/38 (5.26%)  2
Heartburn/dyspepsia  1  3/38 (7.89%)  5
Vomiting  1  4/38 (10.53%)  4
Anorexia  1  5/38 (13.16%)  5
Constipation  1  7/38 (18.42%)  9
Diarrhea  1  9/38 (23.68%)  10
Nausea  1  24/38 (63.16%)  35
General disorders   
Pain - Back  1  2/38 (5.26%)  3
Pain - Extremity-limb  1  2/38 (5.26%)  2
Pain - Joint  1  2/38 (5.26%)  2
Sweating (diaphoresis)  1  2/38 (5.26%)  2
Insomnia  1  3/38 (7.89%)  4
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  4/38 (10.53%)  5
Pain - Muscle  1  5/38 (13.16%)  5
Pain - Generalized  1  5/38 (13.16%)  5
Pain - Head/headache  1  8/38 (21.05%)  12
Rigors/chills  1  10/38 (26.32%)  15
Fatigue (asthenia, lethargy, malaise)  1  34/38 (89.47%)  43
Immune system disorders   
Allergic reaction/hypersensitivity  1  5/38 (13.16%)  5
Metabolism and nutrition disorders   
Potassium, serum-high (hyperkalemia)  1  3/38 (7.89%)  3
Potassium, serum-low (hypokalemia)  1  3/38 (7.89%)  4
Glucose, serum-low (hypoglycemia)  1  4/38 (10.53%)  7
ALT, SGPT (serum glutamic pyruvic transaminase)  1  10/38 (26.32%)  13
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  12/38 (31.58%)  16
Glucose, serum-high (hyperglycemia)  1  16/38 (42.11%)  21
Musculoskeletal and connective tissue disorders   
Fracture  1  2/38 (5.26%)  2
Nervous system disorders   
Mood alteration - Anxiety  1  2/38 (5.26%)  2
Neuropathy: sensory  1  2/38 (5.26%)  2
Dizziness  1  3/38 (7.89%)  4
Mood alteration - Depression  1  6/38 (15.79%)  6
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  4/38 (10.53%)  4
Skin and subcutaneous tissue disorders   
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  2/38 (5.26%)  2
Flushing  1  3/38 (7.89%)  3
Hair loss/alopecia (scalp or body)  1  3/38 (7.89%)  3
Injection site reaction/extravasation changes  1  3/38 (7.89%)  3
Rash/desquamation  1  3/38 (7.89%)  3
Pruritus/itching  1  5/38 (13.16%)  5
1
Term from vocabulary, CTCAE V3.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yogen Saunthararajah, MD
Organization: Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 866-223-8100
EMail: CancerCenterResearch@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01100528    
Other Study ID Numbers: CASE2609
NCI-2010-00640 ( Other Identifier: NCI/CTRP )
First Submitted: April 7, 2010
First Posted: April 9, 2010
Results First Submitted: September 25, 2018
Results First Posted: October 29, 2018
Last Update Posted: February 26, 2019