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	NCI	NCI-91-C-123C NCI-T91-0143N, T91-0143

Objectives

I.  Determine the safety of recombinant human macrophage colony stimulating 
factor (M-CSF) when administered by continuous intravenous infusion at doses 
of 50, 100, 150, or 200 mcg/kg/day for two 14- or 7-day cycles in patients 
with metastatic carcinoma.
II.  Assess the biologic effects and antitumor properties of M-CSF in this 
patient population.
III.  Assess the long-term safety of M-CSF in responding patients who continue 
therapy.

Entry Criteria

Disease Characteristics:

Metastatic carcinoma evidenced by radiographic/radionuclide
scans or unequivocal clinical findings, including but not
limited to the following tumor types:

  Melanoma
  Lymphoma
  Renal cell carcinoma
  Colon cancer
  Breast cancer

Disease must be refractory to all conventional therapy

No brain (parenchymal) metastases

Measurable disease required

Prior/Concurrent Therapy:

Biologic therapy:
  At least 6 weeks since treatment with tumor vaccines or
  monoclonal antibodies

Chemotherapy:
  At least 6 weeks since prior chemotherapy
  No concurrent systemic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 6 weeks since prior radiotherapy

Surgery:
  Not specified

Other:
  No concurrent treatment with steroids, aspirin, or NSAIDs
  (occasional use of short-acting NSAIDs such as ibuprofen
  permitted after discussion with medical monitor)

Patient Characteristics:

Age:
  At least 18

Performance status:
  Not specified

Life expectancy:
  Greater than 12 weeks

Hematopoietic:
  WBC at least 2,000
  AGC at least 500
  Platelets greater than 100,000

Hepatic:
  Bilirubin less than 2.0 mg/dl
  PT less than 1.5 x normal limit

Renal:
  Creatinine less than 2.0 mg/dl

Cardiovascular:
  No NYHA class III/IV heart disease

Pulmonary:
  FEV1 at least 60% of predicted

Other:
  No serious active infection requiring intravenous
     antibiotics
  HIV seronegative
  Hepatitis B seronegative
  No pregnant or lactating women
  Adequate contraception required of fertile patients

Expected Enrollment

Up to 30 patients will be enrolled.  Total duration of the trial will be about 
9-12 months.

Outline

Nonrandomized study.
Biological Response Modifier Therapy.  Recombinant Human Macrophage Colony 
Stimulating Factor (Genetics Institute), M-CSF, NSC-635258.

Cole DJ, Sanda MG, Yang JC, et al.: Phase I trial of recombinant human macrophage colony-stimulating factor administered by continuous intravenous infusion in patients with metastatic cancer. J Natl Cancer Inst 86 (1): 39-45, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

David R. Parkinson, MD, Protocol chair		Ph: 301-496-4345