RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

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Brief Title

RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

Official Title

A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

Brief Summary

      The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus
      and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230.
      Pasireotide is an experimental drug and is not approved by the Food and Drug Administration.
      Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney
      cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it
      may help some patients with melanoma.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Complete Response (CR)

Secondary Outcome

 Median Progression Free Survival(PFS)

Condition

Uveal Melanoma

Intervention

RAD001 (Everolimus) and Pasireotide (SOM230) LAR

Study Arms / Comparison Groups

 RAD001 and pasireotide LAR
Description:  This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

November 2010

Completion Date

June 2016

Primary Completion Date

June 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed metastatic uveal
             melanoma.

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             or = to 20 mm with conventional techniques or as > or = to 10 mm with spiral CT scan.

          -  Patients may have had any number of prior therapies, but cannot have previously been
             treated with a somatostatin analogue or an mTOR inhibitor. At least 3 weeks must have
             elapsed since the last dose of systemic therapy. At least 6 weeks must have elapsed if
             the last regimen included BCNU or mitomycin C. At least 3 months must have elapsed if
             the last regimen included an anti-CTLA4 antibody. If the last regimen included an
             anti-CTLA4 antibody, radiographic disease progression since this therapy must be
             documented.

          -  Age > or = to 18 years. Because no dosing or adverse event data are currently
             available on the use of RAD001 and SOM230 in patients <18 years of age, children are
             excluded from this study but will be eligible for future pediatric trials, if
             applicable.

          -  Life expectancy of greater than 3 months.

          -  ECOG performance status 0 or 1.

          -  Patients must have normal organ and marrow function as defined below:

          -  leukocytes > or = to 3,000/mcL

          -  absolute neutrophil count > or = to 1,500/mcL

          -  platelets > or = to 100,000/mcL

          -  hemoglobin > or = to 9.0 g/dL not requiring transfusions within the past 2 weeks

          -  total bilirubin < 1.5 X institutional upper limit of normal

          -  AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal

          -  Creatinine ≤ 1.5 X institutional upper limit of normal or creatinine clearance less
             than 60 ml/min

          -  Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x
             ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only
             be included after initiation of appropriate lipid lowering medication.

          -  INR ≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin
             or on a stable dose of LMW heparin for >2 weeks at time of study initiation).

          -  Women of childbearing potential must have a negative serum pregnancy test within 14
             days of the administration of the first study treatment. Women must not be lactating.
             Both men and women of childbearing potential must be advised of the importance of
             using effective birth control measures during the course of the study. Oral,
             implantable, or injectable contraceptives may be affected by cytochrome P450
             interactions, and are therefore not considered effective for this study.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Evidence of disease progression, as determined by the investigator.

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents.

          -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases. Treated brain
             metastases must have been stable for at least 2 months.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to RAD001 or SOM230.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or bleeding, severely impaired lung function, or psychiatric illness/social
             situations that would limit compliance with study requirements.

          -  Pregnant women are excluded from this study because RAD001 and SOM230 are agents with
             the potential for teratogenic or abortifacient effects. Because there is an unknown
             but potential risk for adverse events in nursing infants, breast-feeding should be
             discontinued.

          -  Patients with the presence of active or suspected acute or chronic uncontrolled
             infection or with a history of immunocompromise, including a positive HIV test result
             (ELISA and Western blot). The safety of a potentially immunosuppressive drug like
             everolimus is not proven in patients with HIV. HBV DNA and HCV RNA PCR testing are
             required at screening for all patients with a positive medical history based on risk
             factors and/or confirmation of prior HBV/HCV infection (see Section 8.0 and hepatitis
             B/C risk factor screening form.

          -  Baseline QTc > 450 ms.

          -  Patients with risk factors for torsades de pointes, including uncorrected hypokalemia,
             uncorrected hypomagnesemia, family history of long QT syndrome, clinically
             significant/symptomatic bradycardia, high-grade AV block, autonomic neuropathy
             (including that caused by diabetes or Parkinson's disease, uncontrolled
             hypothyroidism, cirrhosis, or the use of concomitant medications known to prolong the
             QT interval.

          -  Patients with a history of syncope, family history of idiopathic sudden death, a
             history of sustained or clinically significant cardiac arrhythmias, symptomatic
             congestive heart failure (NYHA Class III or IV), unstable angina pectoris, sustained
             ventricular tachycardia, ventricular fibrillation, advanced heart block, or a history
             of acute myocardial infarction within the six months preceding enrollment .

          -  No concomitant anti-cancer chemotherapy or other systemic drugs. Palliative radiation
             therapy will be allowed as long as the patient meets all other eligibility criteria.

          -  Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory
             bowel disease), or significant bowel resection that would preclude adequate
             absorption.

          -  Chronic treatment with systemic steroids or another immunosuppressive agent.

          -  Patients should not receive immunization with attenuated live vaccines during study
             period or within 1 week of study entry. Close contact with those who have received
             attenuated live vaccines should be avoided during treatment with RAD001. Examples of
             live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,
             yellow fever, varicella and TY21a typhoid vaccines.

          -  Patients with prior or concurrent malignancy except for the following: adequately
             treated basal cell or squamous cell skin cancer, or other adequately treated in situ
             cancer, or any other cancer from which the patient has been disease free for five
             years.

          -  Patients with a fasting plasma glucose > 1.5 ULN. Note: At the principle
             investigator's discretion, non-eligible patients can be re-screened after adequate
             medical therapy has been instituted.

          -  Patients with symptomatic cholelithiasis.

          -  Patients who have a history of alcohol or drug abuse in the 6 month period prior to
             receiving treatment with pasireotide or RAD001.

          -  History of liver disease, such as cirrhosis or chronic active hepatitis B and C.

          -  Presence of Hepatitis B surface antigen (HbsAg).

          -  Presence of Hepatitis C antibody test (anti-HCV).

          -  History of, or current alcohol misuse/abuse within the past 12 months.

          -  Known gallbladder or bile duct disease, acute or chronic pancreatitis.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Postow, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01252251

Organization ID

10-123


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Michael Postow, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

June 2016