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Lenalidomide in Treating Patients With Stage IV Eye Melanoma
This study has been completed.
First Received: June 2, 2005   Last Updated: April 21, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112606
  Purpose

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. Lenalidomide may also stop the growth of eye melanoma by blocking blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying two different doses of lenalidomide to see how well it works in treating patients with eye melanoma.


Condition Intervention Phase
Intraocular Melanoma
Drug: lenalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response rate (complete and partial response) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: April 2005
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral lenalidomide once daily on days 1-21.
Drug: lenalidomide
Given orally
Arm II: Experimental
Patients receive lenalidomide as in group one at a higher dose.
Drug: lenalidomide
Given orally

Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112606

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000430670, NCI-05-C-0095, NCI-P6501
Study First Received: June 2, 2005
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00112606     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
recurrent intraocular melanoma
metastatic intraocular melanoma

Study placed in the following topic categories:
Eye Neoplasms
Uveal Melanoma
Eye Diseases
Lenalidomide
Melanoma of the Choroid
Angiogenesis Inhibitors
Recurrence
Melanoma
Neuroendocrine Tumors
Ocular Melanoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular Melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Eye Neoplasms
Antineoplastic Agents
Eye Diseases
Neoplasms, Nerve Tissue
Lenalidomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 30, 2009