Trial Outcomes & Findings for Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma (NCT NCT00026221)
NCT ID: NCT00026221
Last Updated: 2016-03-17
Results Overview
Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2016-03-17
Participant Flow
Participant milestones
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
25
|
|
Overall Study
COMPLETED
|
16
|
16
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Arm I (Monoclonal Antibody and Biological Therapy)
n=16 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II (Monoclonal Antibody)
n=16 Participants
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 Participants
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
54 years
n=7 Participants
|
58.4 years
n=5 Participants
|
57 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 patients
n=5 Participants
|
16 patients
n=7 Participants
|
25 patients
n=5 Participants
|
57 patients
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsMeasured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
n=16 Participants
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 Participants
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Objective Response Rate
|
1 patients
|
0 patients
|
6 patients
|
PRIMARY outcome
Timeframe: Up to 2 yearsDefined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
n=15 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
n=16 Participants
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 Participants
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Progression-free Survival
|
3 months
Interval 1.5 to 10.0
|
8.5 months
Interval 1.0 to 47.0
|
4.8 months
Interval 0.9 to 62.5
|
SECONDARY outcome
Timeframe: At baselineAnalyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.
Outcome measures
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
n=16 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
n=16 Participants
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 Participants
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa
|
567 pg/mL
Interval 293.0 to 9719.0
|
633 pg/mL
Interval 212.0 to 9810.0
|
18 pg/mL
Interval 0.0 to 412.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data were not collected and not assessed.
Evaluated using immunohistochemistry.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Continuously from the start of treatment to the end of studyEvaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: Bevacizumab + Iinterferon-alpha-2b
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm II: Bevacizumab Alone
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm III (Monoclonal Antibody and Biological Therapy)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
n=16 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
n=16 participants at risk
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 participants at risk
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Vascular disorders
Subdural Hematoma
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
4.0%
1/25 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Investigations
Elevated Troponin level
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
4.0%
1/25 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
4.0%
1/25 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Vascular disorders
Thrombolembolic event
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.5%
2/16 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
Other adverse events
| Measure |
Arm I: Bevacizumab + Iinterferon-alpha-2b
n=16 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
Arm II: Bevacizumab Alone
n=16 participants at risk
Patients receive bevacizumab as in arm I.
Bevacizumab: Given IV
|
Arm III (Monoclonal Antibody and Biological Therapy)
n=25 participants at risk
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Recombinant Interferon Alfa: Given SC
Bevacizumab: Given IV
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.5%
2/16 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
8.0%
2/25 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
18.8%
3/16 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.0%
3/25 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Nervous system disorders
Headache
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
4.0%
1/25 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.0%
3/25 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Vascular disorders
Hypertension
|
18.8%
3/16 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
18.8%
3/16 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Nervous system disorders
Mental Status Changes
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
General disorders
Pain
|
31.2%
5/16 • Number of events 5
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
25.0%
4/16 • Number of events 4
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/25
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
6.2%
1/16 • Number of events 1
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.0%
3/25 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Blood and lymphatic system disorders
Thrombosis/embolism
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
8.0%
2/25 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
8.0%
2/25 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Psychiatric disorders
Confusion/Memory loss
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.0%
3/25 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
12.0%
3/25 • Number of events 3
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
General disorders
Neutropenia
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
20.0%
5/25 • Number of events 5
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Investigations
AST/ALT
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
8.0%
2/25 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
0.00%
0/16
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
8.0%
2/25 • Number of events 2
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 was utilized for Adverse Event reporting.
|
Additional Information
William E. Carson III, MD
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-6306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60