Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109005
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2005-04-21
Brief Title:
Lenalidomide Revlimid to Treat Advanced Ocular Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Phase II Study of Oral Lenalidomide Revlimid TM an Antiangiogenic and Immunomodulatory Agent in Subjects With Stage IV Ocular Melanoma
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 025 05 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
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 025 05 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
Detailed Description:
Background
Patients with stage IV ocular melanoma have very few available treatment options and an overall poor prognosis
Pre-clinical and early clinical evidence suggest that lenalidomide has activity against solid tumors
This trial is designed to evaluate the safety and efficacy of two different doses of a novel antiangiogenic and immunomodulatory agent lenalidomide Revlimid
Objectives
Primary Objectives
Determine the response rate to lenalidomide at two dose levels for patients with Stage IV ocular melanoma
To determine the toxicity of lenalidomide at two dose levels in this setting
Secondary Objectives
To determine the progression free and overall survival of patients with Stage IV ocular melanoma treated with lenalidomide
When easily accessible obtain tissue at baseline and during therapy to evaluate the effects of these agents on pathways thought to be modulated by lenalidomide in pre-clinical studies
To determine the pharmacokinetics of lenalidomide at these two doses in patients with Stage IV ocular melanoma
To determine if there is a dose level with potentially superior efficacy and acceptable toxicity
Eligibility
Patients 18 years of age with stage IV ocular melanoma who have measurable disease
Patient must be Eastern Cooperative Oncology Group ECOG performance status of 2 and a life expectancy of more than 3 months
Patients must have adequate organ function
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
All patients who are sexually active and able to conceive will be required to use contraception during treatment with lenalidomide
Design
A phase II trial in which patients are randomized to 2 dose levels of lenalidomide administered for 21 days every 28 days for 2 years
76 patients allowing for up to 3 inevaluable patients per dose level will be enrolled over 4 to 5 years
The objective of the trial will be to determine in each of the two groups of patients 5 mg and 25 mg dose levels whether CC5013 is able to be associated with a response rate partial response PR complete response CR that can rule out 10 p0010 in favor of an improved response rate of 30 p1030
Patients with stage IV ocular melanoma have very few available treatment options and an overall poor prognosis
Pre-clinical and early clinical evidence suggest that lenalidomide has activity against solid tumors
This trial is designed to evaluate the safety and efficacy of two different doses of a novel antiangiogenic and immunomodulatory agent lenalidomide Revlimid
Objectives
Primary Objectives
Determine the response rate to lenalidomide at two dose levels for patients with Stage IV ocular melanoma
To determine the toxicity of lenalidomide at two dose levels in this setting
Secondary Objectives
To determine the progression free and overall survival of patients with Stage IV ocular melanoma treated with lenalidomide
When easily accessible obtain tissue at baseline and during therapy to evaluate the effects of these agents on pathways thought to be modulated by lenalidomide in pre-clinical studies
To determine the pharmacokinetics of lenalidomide at these two doses in patients with Stage IV ocular melanoma
To determine if there is a dose level with potentially superior efficacy and acceptable toxicity
Eligibility
Patients 18 years of age with stage IV ocular melanoma who have measurable disease
Patient must be Eastern Cooperative Oncology Group ECOG performance status of 2 and a life expectancy of more than 3 months
Patients must have adequate organ function
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
All patients who are sexually active and able to conceive will be required to use contraception during treatment with lenalidomide
Design
A phase II trial in which patients are randomized to 2 dose levels of lenalidomide administered for 21 days every 28 days for 2 years
76 patients allowing for up to 3 inevaluable patients per dose level will be enrolled over 4 to 5 years
The objective of the trial will be to determine in each of the two groups of patients 5 mg and 25 mg dose levels whether CC5013 is able to be associated with a response rate partial response PR complete response CR that can rule out 10 p0010 in favor of an improved response rate of 30 p1030
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-C-0095 | None | None | None |