Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Lenalidomide in Treating Patients With Stage IV Eye Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-05-C-0095 NCI-P6501, NCT00112606

Special Category: NCI Web site featured trial

Objectives

Primary

1. Determine the response rate in patients with stage IV ocular melanoma treated with two different doses of lenalidomide.
2. Determine the toxicity of this drug in these patients.

Secondary

1. Determine the progression-free and overall survival of patients treated with this drug.
2. Determine the pharmacokinetics of this drug in these patients.
3. Compare the efficacy and acceptable toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ocular melanoma
  • Stage IV disease



• Measurable disease



• No evidence of active brain metastases
  • Prior brain metastases treated with complete excision or radiotherapy allowed provided disease remains asymptomatic and stable for ≥ 6 months by MRI of the brain

Prior/Concurrent Therapy:

Biologic therapy

• At least 4 weeks since prior biologic therapy
• No prior lenalidomide

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin)

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics
• At least 4 weeks since prior surgery

Other

• Recovered from all prior therapy
• No other concurrent antitumor therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Granulocyte count > 1,500/mm³
• Platelet count > 100,000/mm³

Hepatic

• Bilirubin ≤ 2.0 mg/dL
• ALT and AST < 10 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance > 60 mL/min

Cardiovascular

• No New York Heart Association class II-IV congestive heart failure
• No history of unstable or newly diagnosed angina pectoris
• No myocardial infarction within the past 6 months

Pulmonary

• No chronic obstructive lung disease requiring oxygen therapy

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 forms of effective contraception 1 month prior to, during, and for 1 month after completion of study treatment
• No known HIV positivity
• No known hypersensitivity reaction to thalidomide
• No uncontrolled seizure activity
• No serious untreated infection
• No other acute or critical illness

Expected Enrollment

A total of 12-38 patients will be accrued for this study within 2-3 years.

Outcomes

Clinical response rate (complete and partial response)
Toxicity

Outline

This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral lenalidomide once daily on days 1-21.



• Arm II: Patients receive lenalidomide as in group one at a higher dose.

In both arms, courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 1 month, monthly for 2 months, and then every 3 months thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Libutti, MD, Principal investigator		Ph: 301-496-5049 Email: steven_Libutti@nih.gov

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Randomized Study of Oral CC-5013 Lenalidomide (Revlimid), an Antiangiogenic and Immunomodulatory Agent in Subjects with Stage IV Ocular Melanoma
Trial Start Date		2005-04-25
Trial Completion Date		2009-04-15
Registered in ClinicalTrials.gov		NCT00112606
Date Submitted to PDQ		2005-04-25
Information Last Verified		2008-04-27

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