Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - 90 |
| Updated: | 10/14/2017 |
| Start Date: | February 2006 |
| End Date: | September 2009 |
Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
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 combination of HD-IL2 and GM-CSF given the potential synergistic interactions
discussed above.
Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol
will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions
discussed above.
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.
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.
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.
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