Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

Mt. Sinai Medical Center, Miami

Status and phase

Completed

Phase 2

Conditions

Malignant Melanoma

Treatments

Drug: GM-CSF

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00616564

MEL0105

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

16 to 90 years old

Volunteers

No Healthy Volunteers

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.