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VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
This study is ongoing, but not recruiting participants.
First Received: March 20, 2007   Last Updated: May 5, 2009   History of Changes
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450255
  Purpose

RATIONALE: Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.


Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: aflibercept
Other: immunoenzyme technique
Other: pharmacological study
Phase II

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma Surgery
Drug Information available for: Aflibercept
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response rate (complete and partial response) [ Designated as safety issue: No ]
  • Progression-free survival at 4 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity and tolerability [ Designated as safety issue: Yes ]
  • Impact of treatment on laboratory correlates [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: June 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor response rate (complete and partial response) in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap.
  • Compare the progression-free survival of patients treated with this regimen vs historical controls.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxicity and tolerability of this regimen in these patients.
  • Determine the impact of this regimen on laboratory correlates including anti-VEGF Trap antibody testing and pharmacokinetics in these patients.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, prior to course 2, and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by enzyme-linked immunosorbent assay.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV melanoma

    • Cutaneous, ocular, or mucosal melanoma allowed
  • Recurrent, inoperable disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No evidence of CNS disease, including primary brain tumor or brain metastases

    • No brain metastases by MRI or CT scan within the past 4 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
  • PT INR ≤ 1.5 unless on full-dose warfarin
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to agents used in the study
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • No significant traumatic injury within the past 28 days
  • No clinically significant cardiovascular disease, including any of the following:

    • Cerebrovascular accident within the past 6 months
    • Uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg or systolic BP > 180 mm Hg if diastolic BP < 90 mm Hg within the past 3 months
    • Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
    • New York Heart Association class III-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Unstable angina pectoris within the past 6 months
    • Clinically significant peripheral vascular disease within the past 6 months
    • Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
  • No evidence of bleeding diathesis or coagulopathy
  • No concurrent uncontrolled illness, including, but not limited to any of the following:

    • Ongoing or active infection
    • Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy and major surgery
  • No prior chemotherapy or hormonal therapy
  • More than 7 days since prior core visceral organ biopsy
  • More than 4 weeks since prior biologic therapy or radiotherapy
  • More than 28 days since prior major surgery or open biopsy
  • No concurrent major surgery
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent full-dose warfarin with PT INR > 1.5 allowed provided the following criteria are met:

    • INR in range (2-3) on a stable dose of oral anticoagulant or low molecular weight heparin
    • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450255

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Contra Costa Regional Medical Center
Martinez, California, United States, 94553
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Ahmad A. Tarhini, MD, MS UPMC Cancer Centers
  More Information

Additional Information:
No publications provided

Responsible Party: University of California Davis Cancer Center ( David R. Gandara )
Study ID Numbers: CDR0000535719, CCC-PHII-77
Study First Received: March 20, 2007
Last Updated: May 5, 2009
ClinicalTrials.gov Identifier: NCT00450255     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma
extraocular extension melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma
iris melanoma
ciliary body and choroid melanoma, medium/large size

Study placed in the following topic categories:
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Melanoma of the Choroid
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular Melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009