Status:
COMPLETED
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
Lead Sponsor:
Mt. Sinai Medical Center, Miami
Collaborating Sponsors:
Bayer
Chiron Corporation
Conditions:
Malignant Melanoma
Eligibility:
All Genders
16-90 years
Phase:
PHASE2
Brief Summary
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combi...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00616564
Start Date
February 1 2006
End Date
September 1 2009
Last Update
May 3 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Jose Lutzky, MD
Miami Beach, Florida, United States, 33140
2
David Lawson, MD
Atlanta, Georgia, United States, 30322