Trial Outcomes & Findings for Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance (NCT NCT01100528)
NCT ID: NCT01100528
Last Updated: 2019-02-26
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
5 years from time-of-enrollment
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
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
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
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
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance
Baseline characteristics by cohort
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
n=38 Participants
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
|
|---|---|
|
Age, Customized
20-29 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
16 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years from time-of-enrollmentPopulation: All patients enrolled in study
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%.
Outcome measures
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
n=38 Participants
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
|
|---|---|
|
Number of Patients With Disease-free Survival (DFS)
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 32 weeks from start of studyPopulation: All patients enrolled on study regardless of treatment
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
Outcome measures
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
n=38 Participants
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
|
|---|---|
|
Number of Participants With Toxicity or Grade 4 Adverse Events Via CTCAE Version 3.0
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 yrs from start of treatmentPopulation: Information not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
Serious events: 2 serious events
Other events: 38 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
n=38 participants at risk
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
|
|---|---|
|
General disorders
Constitutional Symptoms - Other
|
2.6%
1/38 • Number of events 1 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
2.6%
1/38 • Number of events 1 • During treatment up to 32 weeks
|
Other adverse events
| Measure |
Arm I: Dacarbazine + Recombinant Interferon Alfa-2b
n=38 participants at risk
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
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Lymphocele
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Nervous system disorders
Mood alteration - Anxiety
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Nervous system disorders
Neuropathy: sensory
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Eye disorders
Ocular/Visual - vision impaired
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
General disorders
Pain - Back
|
5.3%
2/38 • Number of events 3 • During treatment up to 32 weeks
|
|
General disorders
Pain - Extremity-limb
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
General disorders
Pain - Joint
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
General disorders
Sweating (diaphoresis)
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
5.3%
2/38 • Number of events 2 • During treatment up to 32 weeks
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • Number of events 4 • During treatment up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.9%
3/38 • Number of events 5 • During treatment up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
General disorders
Insomnia
|
7.9%
3/38 • Number of events 4 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
7.9%
3/38 • Number of events 4 • During treatment up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
Eye disorders
Vision-flashing lights/floaters
|
7.9%
3/38 • Number of events 3 • During treatment up to 32 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.5%
4/38 • Number of events 4 • During treatment up to 32 weeks
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
10.5%
4/38 • Number of events 5 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
10.5%
4/38 • Number of events 7 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
4/38 • Number of events 4 • During treatment up to 32 weeks
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
13.2%
5/38 • Number of events 5 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Anorexia
|
13.2%
5/38 • Number of events 5 • During treatment up to 32 weeks
|
|
General disorders
Pain - Muscle
|
13.2%
5/38 • Number of events 5 • During treatment up to 32 weeks
|
|
General disorders
Pain - Generalized
|
13.2%
5/38 • Number of events 5 • During treatment up to 32 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
13.2%
5/38 • Number of events 5 • During treatment up to 32 weeks
|
|
Nervous system disorders
Mood alteration - Depression
|
15.8%
6/38 • Number of events 6 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Constipation
|
18.4%
7/38 • Number of events 9 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
18.4%
7/38 • Number of events 12 • During treatment up to 32 weeks
|
|
General disorders
Pain - Head/headache
|
21.1%
8/38 • Number of events 12 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
23.7%
9/38 • Number of events 10 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
26.3%
10/38 • Number of events 13 • During treatment up to 32 weeks
|
|
General disorders
Rigors/chills
|
26.3%
10/38 • Number of events 15 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
31.6%
12/38 • Number of events 16 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
31.6%
12/38 • Number of events 26 • During treatment up to 32 weeks
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
42.1%
16/38 • Number of events 21 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
44.7%
17/38 • Number of events 37 • During treatment up to 32 weeks
|
|
Blood and lymphatic system disorders
Platelets
|
44.7%
17/38 • Number of events 23 • During treatment up to 32 weeks
|
|
Gastrointestinal disorders
Nausea
|
63.2%
24/38 • Number of events 35 • During treatment up to 32 weeks
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
89.5%
34/38 • Number of events 43 • During treatment up to 32 weeks
|
Additional Information
Yogen Saunthararajah, MD
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place