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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over CCF-RPC-3272A NCI-B90-0001, B90-0001

Objectives

I.  Examine the toxicity of recombinant human macrophage colony stimulating 
factor (rM-CSF) in patients with advanced malignancies (including advanced 
lung cancer), and determine the maximum tolerated dose of subcutaneously 
administered rM-CSF.
II.  Examine various immunologic and hematologic effects of rM-CSF in this 
patient population.
III.  Monitor any objective antitumor effects of rM-CSF in patients with 
evaluable or measurable advanced cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with advanced malignancy (including non-small cell or recurrent small cell 
lung cancer) who have failed conventional therapy or for whom no standard 
therapy exists.  Absence of CNS metastases must be demonstrated by a normal 
neurologic exam and CT of head.  Objectively measurable disease is not 
required.  Adjuvant chemotherapy is not allowed, and no more than 1 prior 
chemotherapy regimen is allowed, and at least 21 days must have elapsed since 
prior chemotherapy (at least 42 days for nitrosoureas or mitomycin).  Prior 
therapy with M-CSF is not allowed, but 1 prior regimen with G-CSF, GM-CSF, or 
other biologics (e.g., interferon) is permitted provided at least 3 weeks have 
elapsed since such therapy.  At least 28 days must have elapsed since prior 
radiotherapy or hormonal therapy, and at least 14 days must have elapsed since 
any surgery requiring general anesthesia, from which patients must be fully 
recovered.  An ECOG performance status of 0 or 1 and a life expectancy of at 
least 3 months are required, as is adequate organ function, defined as 
follows:  hemoglobin at least 10 g/dl, WBC at least 3,500, AGC at least 1,500, 
and platelets at least 100,000; PT less than 14 seconds and PTT within normal 
institutional limits; creatinine no greater than 1.5 mg/dl; bilirubin no 
greater than 1.5 mg/dl; and DLCO at least 50%.  The following conditions 
exclude:  history of serious cardiac dysfunction (NYHA class 3 or 4); active 
infection requiring antibiotics within 21 days of entry; significant effusions 
and/or ascites; requirement for corticosteroids; and HTLV-III or HBsAg 
positivity.  Patients with a history of another malignancy are eligible.  
Women of childbearing age must have a negative pregnancy test and must be 
using an effective method of contraception.

Expected Enrollment

It is expected that 20-30 patients will be entered and that the study will be 
completed in approximately 6-9 months.

Outline

Nonrandomized study.
Biological Response Modifier Therapy.  Recombinant Human Macrophage Colony 
Stimulating Factor, rM-CSF, NSC-625377.

Bukowski RM, Budd GT, Gibbons JA, et al.: Phase I trial of subcutaneous recombinant macrophage colony-stimulating factor: clinical and immunomodulatory effects. J Clin Oncol 12 (1): 97-106, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cleveland Clinic Foundation Hospital

Ronald Bukowski, MD, Protocol chair		Ph: 216-444-6825; 800-862-7798