Interleukin-7 in Treating Patients With Refractory Solid Tumors
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with refractory solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interleukin-7
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy|
|Study Start Date:||April 2003|
|Study Completion Date:||May 2011|
- Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors.
- Determine a range of biologically active doses of this drug in these patients.
- Determine the biological effects of this drug in these patients.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive interleukin-7 (IL-7) subcutaneously on days 0, 2, 4, 6, 8, 10, 12, and 14 (for a total of 8 doses) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) and "biologically active dose" (BAD) are determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The BAD is defined as the dose that produces a sustained 50% increase in CD3+ count over the patient's baseline without unacceptable toxicity.
Patients are followed at 1, 3, and 6 months and at 1 year after study completion.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3.75-10 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062049
|United States, Maryland|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Chair:||Claude Sportes, MD||National Cancer Institute (NCI)|
|Investigator:||Ronald E. Gress, MD||NCI - Experimental Transplantation and Immunology Branch|