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

NCT00616564 | Completed Phase 2 DMC

• 1 other identifier: MEL0105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignant Melanoma

Keywords

GM-CSF; Interleukin; IL-2; Sargrostim

Outcome Measures

Primary Outcomes (1)

• 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

  one - two years

Interventions

GM-CSF DRUG

Concomitant Priming with GM-CSF

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.

Sponsors & Collaborators

• Mt. Sinai Medical Center, Miami: lead
• Bayer: collaborator
• Chiron Corporation: collaborator

Study Sites (2)

Jose Lutzky, MD

Miami Beach, Florida, 33140, United States

Location

David Lawson, MD

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jose Lutzky, M.D.

  Mount Sinai Medical Center Miami Beach

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Jose Lutzky, M.D.

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: February 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (2)