Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mt. Sinai Medical Center, Miami
With
Bayer
Chiron Corporation
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.
Age
16–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
