Phase 2 Completed N=57 Randomized Treatment

Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

Recurrent Melanoma · Stage IV Skin Melanoma

Source: ClinicalTrials.gov NCT00026221 ↗

Enrolled (actual)

Serious AEs

10.5%

Results posted

Mar 2016

Primary outcomePrimary: Objective Response Rate — 1; 0; 6 patients

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate	1; 0; 6	—
PRIMARY Progression-free Survival	3; 8.5; 4.8	—
SECONDARY Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa	567; 633; 18	—
SECONDARY New Vessel Formation in Patient Tumor Samples	—	—

Eligibility Criteria

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 = = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00026221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.