Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed over 18 MSKCC-91017 NCI-B90-0015, B90-0015

Objectives

I.  Evaluate the toxicity, MTD, and antitumor effects of mouse monoclonal 
antibody R24 (MOAB R24) given with a fixed dose of recombinant human 
macrophage colony stimulating factor (M-CSF) in patients with advanced 
melanoma.

II.  Study the biologic effects of MOAB R24 and M-CSF, including complement 
activation, monocyte activation, antibody-dependent monocyte-mediated 
cytotoxicity, development of human antimouse antibodies, and cellular tumor 
infiltration.

Entry Criteria

Disease Characteristics:

Histologically proven metastatic Stage III/IV melanoma

  Histology must be confirmed by the Pathology Department of
  MSKCC

Ocular melanoma excluded

No concurrent CNS metastases

Evaluable disease required
  Measurable disease not required

Prior/Concurrent Therapy:

Biologic therapy:
  No prior M-CSF or MOAB R24 (diagnostic or immunotherapeutic)
  No more than 1 prior immunotherapy regimen
  At least 4 weeks since prior immunotherapy
  Full recovery from prior immunotherapy required

Chemotherapy:
  No more than 1 prior course of systemic chemotherapy other
  than cyclophosphamide administered as an adjuvant with
  vaccine therapy or prior limb perfusion therapy

Endocrine therapy:
  At least 3 weeks since prior hormonal therapy

Radiotherapy:
  At least 4 weeks since prior radiotherapy
  Full recovery from prior radiotherapy required

Surgery:
  Full recovery from any prior surgery required

Other:
  At least 3 weeks since treatment with aspirin or NSAIDs
  No requirement for concurrent corticosteroids

Patient Characteristics:

Age:
  Over 18

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 3 months

Hematopoietic:
  Granulocytes greater than 2,000
  Platelets greater than 160,000

Hepatic:
  Bilirubin less than 1.5 mg/dl

Renal:
  Creatinine less than 1.7 mg/dl

Cardiovascular:
  No NYHA class III/IV heart disease

Other:
  No serious active infection requiring antibiotics
  No other serious intercurrent illness
  No history of other concurrent malignancies except:
     Nonmelanomatous skin cancer
     In situ cervical carcinoma
  No pregnant or lactating women

Expected Enrollment

A maximum of 36 patients will be entered.  The study is expected to be 
completed in approximately 18-24 months.

Outline

Nonrandomized study.

Biological Response Modifier Therapy.  Mouse Monoclonal Antibody R24, MOAB 
R24, NSC-608918; Recombinant Human Macrophage Colony Stimulating Factor 
(Genetics Institute), M-CSF, NSC-625377.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Dean Bajorin, MD, Protocol chair		Ph: 646-422-4333; 800-525-2225