Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients with Stage IV Melanoma that Cannot be Removed by Surgery

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-001863
    NCT ID: NCT02020707
    Sponsor Protocol Number: MC1371

About this study

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab many kill more tumor cells.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologic proof of surgically unresectable stage IV malignant melanoma
  • At least one prior systematic therapy in the metastatic setting
  • Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm with chest x-ray, or as ≥ 1.0 cm with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT component of a positron emission tomography (PET)/CT; NOTE: disease that is measurable by physical examination only is not eligible
  • Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet hemoglobin [Hgb] requirement)
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3
  • Platelet count (PLT) ≥ 100,000/mm^3
  • Total bilirubin ≤ 1.5 mg/dL or direct bilirubin ≤ 0.4 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 2.5 x upper limit of normal (ULN)
  • Creatinine ≤ 1.5 x ULN
  • Absence of proteinuria at screening as demonstrated by one of the following:
    • Urine protein/creatinine (UPC) ratio < 1.0 at screening
    • Urine dipstick for proteinuria < 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Ability to understand and the willingness to sign a written informed consent document
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Life expectancy ≥ 90 days (3 months)
  • Willing to provide tissue and blood samples for correlative research purposes
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

Exclusion Criteria:

  • Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
  • Prior therapy with an angiogenesis inhibitor
  • Any anti-cancer therapy or investigational agents ≤ 4 weeks prior to registration
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of inflammatory bowel disease, diverticulitis, pancreatitis, or a grade 3 or 4 bowel toxicity from an immune checkpoint inhibitor
  • An ECOG performance status score that is neither 0 or 1
  • Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
  • Brain metastases per MRI or CT at any time prior to registration; NOTE: patients that have had primary therapy for brain metastasis (i.e. surgical resection, whole brain radiation, or SRT even if stable) are not eligible
  • Any of the following:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Other active malignancy ≤ 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  • Other medical conditions including but not limited to:
    • History of liver disease such as cirrhosis, chronic active hepatitis, chronic persistent hepatitis or hepatitis B or C
    • Active infection requiring parenteral antibiotics
    • Immuno-compromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
    • New York Heart Association class II-IV congestive heart failure (serious cardiac arrhythmia requiring medication)
    • Myocardial infarction or unstable angina ≤ 6 months prior to registration
    • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
    • Clinically significant peripheral vascular disease
    • History of central nervous system (CNS) disease (e.g., primary brain tumor, vascular abnormalities, etc.) clinically significant stroke or transient ischemic attack (TIA) ≤ 6 months prior to registration, seizures not controlled with standard medical therapy
    • History of hypertensive crisis or hypertensive encephalopathy
    • Therapeutic anticoagulation requiring international normalized ratio (INR) > 2.0

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions