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Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma


Phase 2
16 Years
90 Years
Not Enrolling
Both
Malignant Melanoma

Thank you

Trial Information

Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Objective

Outcome Description:

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

Outcome Time Frame:

one - two years

Safety Issue:

No

Principal Investigator

Jose Lutzky, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Sinai Medical Center Miami Beach

Authority:

United States: Institutional Review Board

Study ID:

MEL0105

NCT ID:

NCT00616564

Start Date:

February 2006

Completion Date:

September 2009

Related Keywords:

  • Malignant Melanoma
  • GM-CSF
  • Interleukin
  • IL-2
  • Sargrostim
  • Melanoma

Name

Location

Jose Lutzky, MDMiami Beach, Florida  33140
David Lawson, MDAtlanta, Georgia  30322