RAD001 Plus Bevacizumab in Metastatic Melanoma

November 22, 2021 updated by: SCRI Development Innovations, LLC

A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression.

During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.

Fifty-five patients will be enrolled in this multi-centered study

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Cancer Care and Research
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Saint Petersburg, Florida, United States, 33705
        • Gulfcoast Oncology Associates
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Oncology Hematology Associates of SW Indiana
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Grand Rapids Clinical Oncology Program
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Louis Cancer Care
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
        • Consultants in Medical Oncology and Hematology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology & Hematology Associates
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC
    • Texas
      • San Antonio, Texas, United States, 78258
        • South Texas Oncology and Hematology
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed melanoma.
  2. Unresectable stage IV disease, or recurrent disease with metastases.
  3. Measurable disease (by Response Evaluation Criteria in Solid Tumors [RECIST]) or measurable skin lesions.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  5. Life expectancy >=12 weeks.
  6. Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
  7. Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
  8. Absolute neutrophil count (ANC) >=1500/µL, and platelets >=100,000/µL.
  9. Serum creatinine <=2.0 mg/dL.
  10. 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.

Exclusion Criteria:

  1. Previous treatment with bevacizumab or other anti-angiogenesis agents.
  2. Previous treatment with mTOR inhibitors.
  3. Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
  4. Treatment with investigational agents within 4 weeks of study entry.
  5. Treatment with more than two previous chemotherapy regimens.
  6. Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
  7. Female patients who are pregnant or breastfeeding.
  8. Central nervous system (CNS) involvement by metastatic melanoma.
  9. CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).

  10. 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.
  11. Acute myocardial infarction (MI) with the previous 6 months.
  12. 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.
  13. Clinical history of hemoptysis or hematemesis.
  14. Clinical evidence or history of a bleeding diathesis or coagulopathy.
  15. Major surgical procedures, fine-needle aspirations, or core biopsies with 7 days of starting treatment.
  16. Patients with PEG tubes or G-tubes.
  17. 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).

  18. Proteinuria at screening as demonstrated by either

    1. Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR
    2. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Drug: Bevacizumab
15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.
Other Names:
  • Avastin
Drug: Everolimus
10 mg by mouth daily
Other Names:
  • Afinitor
  • RAD001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 13 months
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: 1 year
Overall Survival is defined as the length of time, in months, that patients were alive from their first date of protocol treatment until death. For patients who were alive at the time of calculation, follow-up time was censored at date of last contact. The percentage of patients who were alive at 1 year is reported here. This was estimated using the Kaplan Meier method.
1 year
Objective Response Rate (ORR)
Time Frame: 13 months
The percentage of patients who experience an objective benefit from treatment (CR+PR). The response categories were assigned using RECIST criteria. Complete Response (CR) = Disappearance of all target lesions ; Partial Response (PR) = >=30% decrease in the sum of the longest diameter of target lesions.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Novartis
Genentech, Inc.

Investigators

  • Study Chair: John D. Hainsworth, M.D., SCRI Development Innovations, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI MEL 16

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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