- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026221
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given IV
Other Names:
Given SC
Other Names:
|
Experimental: Arm II (monoclonal antibody)
Patients receive bevacizumab as in arm I.
|
Given IV
Other Names:
|
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.
|
Given IV
Other Names:
Given SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 2 years
|
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
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Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa
Time Frame: At baseline
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Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.
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At baseline
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New Vessel Formation in Patient Tumor Samples
Time Frame: Up to 2 years
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Evaluated using immunohistochemistry.
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Up to 2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Continuously from the start of treatment to the end of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Carson, Ohio State University Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Interferons
- Interferon-alpha
- Bevacizumab
Other Study ID Numbers
- NCI-2009-00006 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA016058 (U.S. NIH Grant/Contract)
- N01CM62207 (U.S. NIH Grant/Contract)
- CDR0000069010
- 2001C0185
- OSU-01H0185
- 0132
- NCI-2669
- OSU 0132 (Other Identifier: Ohio State University Comprehensive Cancer Center)
- 2669 (CTEP)
- R21CA093071 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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