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

Primary Purpose

Malignant Melanoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GM-CSF

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring GM-CSF, Interleukin, IL-2, Sargrostim

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Jose Lutzky, MD
David Lawson, MD

Outcomes

Primary Outcome Measures

Primary Objective

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00616564

First Posted

February 4, 2008

Last Updated

May 2, 2012

Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

Bayer, Chiron Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00616564

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

Bayer, Chiron Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

Keywords

GM-CSF, Interleukin, IL-2, Sargrostim

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

GM-CSF

Intervention Description

Concomitant Priming with GM-CSF

Primary Outcome Measure Information:

Title

Primary Objective

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

Time Frame

one - two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Lutzky, M.D.

Organizational Affiliation

Mount Sinai Medical Center Miami Beach

Official's Role

Study Chair

Facility Information:

Facility Name

Jose Lutzky, MD

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

David Lawson, MD

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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