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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma

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Trial Information

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


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


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease

Outcome Time Frame:

13 months

Safety Issue:

No

Principal Investigator

John D. Hainsworth, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI MEL 16

NCT ID:

NCT00591734

Start Date:

January 2008

Completion Date:

October 2011

Related Keywords:

  • Metastatic Melanoma
  • Metastatic Melanoma
  • Everolimus
  • RAD001
  • Bevacizumab
  • Melanoma

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
South Texas Oncology and HematologySan Antonio, Texas  78229
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Virginia Cancer InstituteRichmond, Virginia  23230
Methodist Cancer CenterOmaha, Nebraska  68114
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Gulfcoast Oncology AssociatesSt. Petersburg, Florida  33705
St. Louis Cancer CareChesterfield, Missouri  63017
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Watson Clinic Center for Cancer Care and ResearchLakeland, Florida  33805
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Consultants in Medical Oncology and HematologyDrexel Hill, Pennsylvania  19026
Chattanooga Oncology & Hematology AssociatesChattanooga, Tennessee  37404