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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062049 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Biological: recombinant interleukin-7 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2003 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy meeting both of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent chronic anticoagulants (e.g., high-dose warfarin, heparin, or aspirin)
Contacts and Locations| 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 | |
| Methodist Hospital | |
| 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 |
More Information
| Study ID Numbers: | CDR0000304451, NCI-03-C-0152I |
| Study First Received: | June 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062049 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |