- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00616564
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
Study Overview
Detailed Description
The primary objectives of this phase II multicenter trial are to:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population.
The secondary objectives are to:
Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain immunological data from the use of this regimen in vivo (as separate project: Moffitt?).
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF. GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for unexpected toxicity.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Florida
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Miami Beach, Florida, United States, 33140
- Jose Lutzky, MD
-
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Georgia
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Atlanta, Georgia, United States, 30322
- David Lawson, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV or unresectable advanced melanoma
- Age at least 16 years.
- ECOG performance status of 0-1
- Life expectancy > 3 months
Adequate major organ function to tolerate therapy, as defined by:
- Total bilirubin 2.0 mg/dL.
- Creatinine 1.8 mg/dL.
- WBC 3,000/mm3.
- Platelet count 100,000/mm3.
- Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation
- Left ventricular ejection fraction > 40%
- Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required.
- Patients must give written informed consent
Exclusion Criteria:
- No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
- No more than 2 prior chemotherapy regimens are allowed.
- No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
- No concurrent use of systemic corticosteroids
- Pregnant and/or lactating are excluded
- No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies.
- No treatment for melanoma within the previous 4 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Objective
Time Frame: one - two years
|
Determine the 1 and 2-year survival of patients treated according to protocol.
Assess the safety and toxicity of this regimen in this patient population
|
one - two years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jose Lutzky, M.D., Mount Sinai Medical Center Miami Beach
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEL0105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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