Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma
11 other identifiers
interventional
57
1 country
2
Brief Summary
This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2001
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 9, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
March 17, 2016
CompletedMarch 17, 2016
February 1, 2016
12 years
November 9, 2001
December 16, 2015
February 18, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate
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.
Up to 2 years
Progression-free Survival
Defined 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
Up to 2 years
Secondary Outcomes (2)
Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa
At baseline
New Vessel Formation in Patient Tumor Samples
Up to 2 years
Other Outcomes (1)
Toxicity
Continuously from the start of treatment to the end of study
Study Arms (3)
Arm I (monoclonal antibody and biological therapy)
EXPERIMENTALPatients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Arm II (monoclonal antibody)
EXPERIMENTALPatients receive bevacizumab as in arm I.
Arm III (monoclonal antibody and biological therapy)
EXPERIMENTALPatients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.
Interventions
Given SC
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed cutaneous malignant melanoma
- Must meet one of the following criteria:
- Clinical evidence of metastatic disease
- Unresectable regional lymphatic disease
- Extensive in transit recurrent disease
- Measurable disease
- At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
- No known brain metastases
- No ocular melanoma
- Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- Performance status - Karnofsky 60-100%
- More than 6 months
- White blood cells (WBC) at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William E. Carson III, MD
- Organization
- The Ohio State University Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
William Carson
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2001
First Posted
January 27, 2003
Study Start
November 1, 2001
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
March 17, 2016
Results First Posted
March 17, 2016
Record last verified: 2016-02