Lenalidomide (Revlimid) to Treat Advanced Ocular Melanoma

NCT00109005 | Completed Phase 2 Results

• 2 other identifiers: 05009505-C-0095
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site). It will also examine the toxicity and blood effects of Revlimid. Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this study. Candidates are screened with a medical history and physical and examination, blood and urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or positron emission tomography (PET). Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24 hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see how the body handles the drug. If the drug is well tolerated, patients are sent home with a 21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years. Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose may be adjusted according to the laboratory test results. If unacceptable toxicity occurs, treatment may be stopped. Patients who agree to be biopsied undergo this procedure before treatment begins and at the end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is examined under a microscope. Patients return to NIH after the first month of treatment and then every 3 months to evaluate their tumors and treatment of side effects. The visits include a physical examination, x-rays and scans to evaluate tumors. Visits are scheduled every 3 months while on treatment; then every 3 months for 2 years afterwards; then every 4 months for 1 year; and as needed after that. Patients will have a brain magnetic resonance imaging scan once a year to watch for new tumor areas.

Conditions

Melanoma

Keywords

Response Rate; Toxicity; Progression-Free Survival; Overall Survival; Pharmacokinetic; Ocular Melanoma

Outcome Measures

Primary Outcomes (2)

• Clinical Responses in Patients With Metastatic Ocular Melanoma

  Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

  12 months

• Number of Participants With Adverse Events

  Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

  24 months

Secondary Outcomes (5)

• Progression Free Survival

  up to 2 years

• Overall Survival

  up to 2 years

• Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg

  Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.

• Determine Dose Level With Superior Efficacy and Acceptable Toxicity

  up to 2 years

• Evaluate Effects of Lenalidomide on Pathways

  Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.

Study Arms (2)

Cohort 1 - 25 mg lenalidomide (Revlimid)

EXPERIMENTAL

oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks

Drug: Revlimid

Cohort 2 - 5 mg lenalidomide (Revlimid)

EXPERIMENTAL

oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks

Drug: Revlimid

Interventions

Revlimid DRUG

oral dose (1 capsule) 25 mg per day 7 days a week for cohort 1 oral dose (1 capsule) 5 mg per day 7 days a week for cohort 2

Also known as: Lenalidomide

Cohort 1 - 25 mg lenalidomide (Revlimid); Cohort 2 - 5 mg lenalidomide (Revlimid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with stage IV ocular melanoma, who have measurable disease will be considered.
• Patients must have histopathological documentation of ocular melanoma confirmed in the Laboratory of Pathology/National Cancer Institute (NCI) of the Clinical Center at the National Institutes of Health. This can be from tissue obtained outside the National Institutes of Health (NIH).
• Patient must be Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
• Patients must have a life expectancy of more than 3 months.
• Hematological eligibility parameters (prescreen):
• Granulocyte count greater than 1,500/mm\^3
• Platelet count greater than 100,000/mm\^3
• If the creatinine is greater than 1.5 mg/dL, obtain a 24 hour urine collection. Creatinine clearance must be greater than 60 mL/min/1.73m\^2.
• Hepatic function: bilirubin (total) less than or equal to 2.0 mg/dl; Alanine aminotransferase (ALT) less than 10 x upper limit of normal; Aspartate aminotransferase (AST) less than 10 x upper limit of normal.
• Patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified above.
• Patients must not have had prior surgery, chemotherapy, hormonal therapy, radiation therapy, or biological therapy, for at least 4 weeks prior to starting study medication. Patients who were receiving mitomycin C, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy.
• Patients must not have an acute, critical illness, including a serious untreated infection.
• Patients must be willing to return to the National Institutes of Health (NIH) for follow-up visits.
• All patients who are sexually active and able to conceive will be required to use contraception during treatment with lenalidomide.
• Only two criteria are allowed by the Food and Drug Administration (FDA) for the status of not of child bearing potential: hysterectomy or menopause for 24 consecutive months. Women of child bearing potential will be required to use two methods of birth control, one highly effective method and one additional method, at the same time during treatment and for one month after the completion of lenalidomide treatment. These methods must be used for at least four weeks before starting lenalidomide, during treatment, and for at least four weeks following the last dose of lenalidomide. Acceptable forms of birth control include:

You may not qualify if:

• Patients with evidence of active brain metastases will be excluded. Patients must have had a complete excision or radiotherapy and remain asymptomatic with stable disease as shown by magnetic resonance imaging (MRI) for at least six months.
• Patients who are pregnant or lactating. No data is currently available about the excretion of lenalidomide in breast milk. Although no preclinical data suggest teratogenicity with this compound, because of the relationship to thalidomide, we will exclude patients who are pregnant or lactating.
• Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), New York class II-IV congestive heart failure, chronic obstructive lung disease requiring oxygen therapy or uncontrolled seizure activity are not eligible.
• Patients who are known positive for human immunodeficiency virus (HIV) as it may increase their risk of infection since lenalidomide has effects on cells involved in the immune system.
• Patients who have had prior therapy with lenalidomide.
• Patients with known hypersensitivity reaction to lenalidomide.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Gragoudas ES, Egan KM, Seddon JM, Glynn RJ, Walsh SM, Finn SM, Munzenrider JE, Spar MD. Survival of patients with metastases from uveal melanoma. Ophthalmology. 1991 Mar;98(3):383-9; discussion 390. doi: 10.1016/s0161-6420(91)32285-1.

  PMID: 2023760 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Caryn Steakley
• Organization: National Cancer Institute, National Institutes of Health

steaklec@mail.nih.gov

301-435-3685

Study Officials

• Caryn Steakley

  National Cancer Institute, National Institutes of Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2005
• First Posted: April 22, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 2, 2017
• Results First Posted: October 30, 2012

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)