Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
|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: NCT00026221|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma Stage IV Skin Melanoma||Biological: Recombinant Interferon Alfa Biological: Bevacizumab||Phase 2|
I. Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Patients also receive low-dose interferon alpha (IFN-alpha) subcutaneously (SC) on days 1-14.
ARM II: Patients receive bevacizumab as in arm I.
ARM III: Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12. In all arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo restaging at the completion of course 12. Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year. Patients with stable disease after 1 year of treatment with bevacizumab and IFN-alpha (arms I and III) may continue to receive bevacizumab alone every 21 days (as in arm II) in the absence of disease progression.
Patients are followed every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Arm I (monoclonal antibody and biological therapy)
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.
Biological: Recombinant Interferon Alfa
Other Name: IFN-A
Experimental: Arm II (monoclonal antibody)
Patients receive bevacizumab as in arm I.
Experimental: 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.
Biological: Recombinant Interferon Alfa
Other Name: IFN-A
- Objective Response Rate [ Time Frame: Up to 2 years ]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.
- Progression-free Survival [ Time Frame: Up to 2 years ]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
- Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa [ Time Frame: At baseline ]Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.
- New Vessel Formation in Patient Tumor Samples [ Time Frame: Up to 2 years ]Evaluated using immunohistochemistry.
- Toxicity [ Time Frame: Continuously from the start of treatment to the end of study ]Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
- No clinical evidence of coagulopathy
- Bilirubin =< 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's disease provided patient is stable and asymptomatic)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal (ULN)
- Prothrombin time (PT)/International normalized ratio (INR) less than 1.5
- Creatinine =< 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Protein < 1,000 mg on 24-hour urine collection for patients with proteinuria >= 1+
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
No history of thrombosis (e.g., deep vein thrombosis), unless the following criteria are met:
- INR in normal range (usually 2-3) AND on a stable dose of warfarin or low molecular weight heparin
- No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., known varices or tumor involving major vessels)
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or interferon alfa
- No ongoing or active infection
- No other concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- Human immunodeficiency virus (HIV) allowed provided otherwise well
- At least 4 weeks since prior adjuvant interferon alfa
- No prior interferon alfa for metastatic disease
No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2 [IL-2])
- Prior IL-2 allowed for patients randomized to arm III only
- No prior investigational antiangiogenic agents
- No more than 1 prior chemotherapy regimen for metastatic disease
- At least 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior radiotherapy and recovered
- No other concurrent investigational agents
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): NCT00026221
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||William Carson||Ohio State University Comprehensive Cancer Center|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
NCI-2009-00006 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
OSU 0132 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
2669 ( Other Identifier: CTEP )
N01CM62207 ( U.S. NIH Grant/Contract )
R21CA093071 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
|First Posted:||January 27, 2003 Key Record Dates|
|Results First Posted:||March 17, 2016|
|Last Update Posted:||March 17, 2016|
|Last Verified:||February 2016|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Angiogenesis Modulating Agents
Physiological Effects of Drugs