RAD001 Plus Bevacizumab in Metastatic Melanoma

Completed · Phase 2

Conditions studied: Metastatic Melanoma

In brief

This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.

Key facts

Study ID

NCT00591734

Run by

SCRI Development Innovations, LLC

People needed

57

Starts

2008-01-01

Expected to finish

2011-10-01

Last updated by the study team

2021-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed melanoma.
• Unresectable stage IV disease, or recurrent disease with metastases.
• Measurable disease (by Response Evaluation Criteria in Solid Tumors [RECIST]) or measurable skin lesions.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Life expectancy >=12 weeks.
• Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
• Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
• Absolute neutrophil count (ANC) >=1500/µL, and platelets >=100,000/µL.
• Serum creatinine <=2.0 mg/dL.
• Serum bilirubin <=1.5 mg/dL institutional upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN or <5 × ULN in patients with documented liver metastases.

You may not qualify if…

• Previous treatment with bevacizumab or other anti-angiogenesis agents.
• Previous treatment with mTOR inhibitors.
• Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
• Treatment with investigational agents within 4 weeks of study entry.
• Treatment with more than two previous chemotherapy regimens.
• Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
• Female patients who are pregnant or breastfeeding.
• Central nervous system (CNS) involvement by metastatic melanoma.
• CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).
• Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
• Severely impaired lung function.
• Uncontrolled diabetes as defined by fasting serum glucose >1.5 ULN,
• Any acute or chronic uncontrolled infection/disorder.
• Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
• Any acute or chronic uncontrolled infection/disorder.
• Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardize by the treatment with the study therapy.
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
• Acute myocardial infarction (MI) with the previous 6 months.
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, New York Heart Association [NYHA] Class II or greater congestive heart failure [CHF], serious cardiac arrhythmia requiring medication), or >= grade 2 vascular disease.
• Clinical history of hemoptysis or hematemesis.
• Clinical evidence or history of a bleeding diathesis or coagulopathy.
• Major surgical procedures, fine-needle aspirations, or core biopsies with 7 days of starting treatment.
• Patients with PEG tubes or G-tubes.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Proteinuria at screening as demonstrated by either

Where it is running

• Florida Cancer Specialists — Fort Myers, Florida, United States
• Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Grand Rapids Clinical Oncology Program — Grand Rapids, Michigan, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Methodist Cancer Center — Omaha, Nebraska, United States
• Consultants in Medical Oncology and Hematology — Drexel Hill, Pennsylvania, United States
• Chattanooga Oncology & Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• South Texas Oncology and Hematology — San Antonio, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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