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A Phase II Study of Combination Oral CC-5013 Lenalidomide (Revlimid™), Oral Sunitinib (Sutent™) and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma

Phase 2
18 Years
Not Enrolling
Intraocular Melanoma, Malignant Conjunctival Neoplasm

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Trial Information

A Phase II Study of Combination Oral CC-5013 Lenalidomide (Revlimid™), Oral Sunitinib (Sutent™) and Low Dose Oral Metronomic Cyclophosphamide for the Treatment of Stage IV Ocular Melanoma



- Determine the response rate in patients with stage IV ocular melanoma treated with
lenalidomide, sunitinib malate, and low-dose metronomic cyclophosphamide.


- Determine the toxicity of this regimen in these patients.

- Determine the progression-free survival of patients treated with this regimen.

- Obtain blood, urine, and tissue samples from these patients, when easily accessible, to
determine the effects of this regimen on pathways thought to have been modulated by
this regimen in pre-clinical studies.

OUTLINE: This is nonrandomized, uncontrolled, open-label study.

Patients receive oral lenalidomide, oral sunitinib malate*, and oral low-dose
cyclophosphamide once daily on days 1-28. Treatment repeats every 28 days for up to 2 years
in the absence of disease progression or unacceptable toxicity.

NOTE: *Some patients will not receive sunitinib malate during course 1.

After completion of study treatment, patients are followed every 3 months for 2 years, every
4 months for 3 years and then annually thereafter.

Inclusion Criteria


- Histologically confirmed ocular melanoma

- Stage IV disease

- Measurable disease

- No active brain metastases

- Patients with brain metastases must have had a complete excision or radiotherapy
and remain asymptomatic with stable disease by magnetic resonance imaging (MRI)
or computed tomography (CT) scan for ≥ 6 months


- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Life expectancy > 3 months

- Granulocyte count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

- Bilirubin ≤ 2.0 mg/dL

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 10 times upper
limit of normal (ULN)

- Prothrombin time (PT)/partial thromboplastin time (PTT)/International Normalized
Ratio (INR) normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use one highly effective method of contraception (with an
additional method) or barrier methods of contraception for ≥ 4 weeks before, during,
and for ≥ 4 weeks after completion of study therapy

- Ejection fraction normal by echocardiogram

- No acute, critical illness, including serious untreated infection

- No history of any of the following:

- Unstable or newly diagnosed angina pectoris

- Myocardial infarction within the past 6 months

- New York Heart Association class II-IV heart disease

- Congestive heart failure

- Chronic obstructive lung disease requiring oxygen therapy

- Chronic uncontrollable hypertension

- Uncontrolled seizure activity

- No known human immunodeficiency virus (HIV) positivity

- No known hypersensitivity reaction to thalidomide, lenalidomide, sunitinib malate, or


- See Disease Characteristics

- Recovered from all prior therapy

- At least 4 weeks since prior surgery, chemotherapy (6 weeks for mitomycin C,
nitrosoureas, or carboplatin), hormonal therapy, radiotherapy, or biological therapy

- No concurrent grapefruit or grapefruit juice

- No other concurrent antitumor therapy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete and Partial Response)

Outcome Description:

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

April 2009

Related Keywords:

  • Intraocular Melanoma
  • Malignant Conjunctival Neoplasm
  • recurrent intraocular melanoma
  • metastatic intraocular melanoma
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • iris melanoma
  • conjunctival melanoma
  • Neoplasms
  • Conjunctival Neoplasms
  • Melanoma
  • Uveal Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182