Back to Search
Start Over
Phase I trial of escalating doses of interleukin-1 beta in combination with a fixed dose of interleukin-2
- Source :
- Journal of Clinical Oncology. 13:482-489
- Publication Year :
- 1995
- Publisher :
- American Society of Clinical Oncology (ASCO), 1995.
-
Abstract
- PURPOSE Interleukin-1 (IL-1) and IL-2 have synergistic antitumor and myelostimulatory activities. We investigated the clinical and biologic effects of IL-1/IL-2 therapy. PATIENTS AND METHODS Twenty patients with metastatic cancer, divided into five cohorts, were treated with escalating doses of IL-1 beta (0.005 to 0.2 micrograms/kg/d) administered as a 30-minute intravenous (IV) infusion on days 1 to 4, combined with a fixed dose of IL-2 (0.1 mg/m2/d) administered by continuous IV infusion on days 1 to 4. The 4-day cycles were repeated weekly for up to 8 weeks in the absence of toxicity and/or progressive disease. RESULTS Patients tolerated up to 0.2 microgram/kg/d of IL-1 beta in combination with IL-2 without severe adverse effects. Peripheral-blood CD4-to-CD8 ratios and lymphokine-activated killer (LAK) activity were higher at the lower doses (0.005 to 0.05 microgram/kg/d) of IL-1 beta and higher than that of a cohort of patients treated with IL-2 alone. WBC counts, primarily neutrophils, increased significantly with higher doses of IL-1 beta (0.1 to 0.2 microgram/kg/d). Platelet counts were not significantly altered. Increases in serum IL-6, interferon gamma (IFN-gamma), and soluble IL-2 receptor levels were observed, but did not vary with IL-1 beta dose. Tumor regressions were observed in patients with colorectal cancer, melanoma, and renal cell carcinoma. CONCLUSION IL-1 beta cancer be administered in combination with IL-2 with acceptable toxicity. Our results suggest that the addition of even low-dose IL-1 beta to IL-2 may be associated with potentially beneficial biologic activity; higher doses of IL-1 beta (0.1 to 0.2 microgram/kg/d) may add potentially beneficial hematologic activity.
- Subjects :
- Adult
Male
Interleukin 2
Cancer Research
Time Factors
Neutrophils
medicine.drug_class
Microgram
medicine.medical_treatment
CD4-CD8 Ratio
Pharmacology
Immunostimulant
Leukocyte Count
Adjuvants, Immunologic
Carcinoma
medicine
Humans
Neoplasm Metastasis
Infusions, Intravenous
Beta (finance)
Adverse effect
Carcinoma, Renal Cell
Melanoma
Aged
business.industry
Immunotherapy
Middle Aged
medicine.disease
Kidney Neoplasms
Oncology
Toxicity
Interleukin-2
Female
Colorectal Neoplasms
Peptides
business
Interleukin-1
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....a398a0196f00748eff34ffed51006d04