Interleukin-7 in Treating Patients With Refractory Solid Tumors
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the safety and dose-limiting toxicity of biologically active doses of interleukin-7 in patients with refractory solid tumors.
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Determine a range of biologically active doses of this drug in these patients.
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Determine the biological effects of this drug in these patients.
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Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignancy meeting both of the following criteria:
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No known curative therapy
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Failed standard therapy, defined as either lack of response OR disease progression (i.e., at least 25% increase in disease or new disease)
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Measurable or evaluable disease
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No hematopoietic malignancies
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No primary carcinoma of the lung
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- At least 3 months
Hematopoietic
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Absolute neutrophil count greater than 1,000/mm^3
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Platelet count greater than 100,000/mm^3
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No proliferative hematologic disease
Hepatic
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AST and ALT less than 3 times upper limit of normal (ULN)
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PT/PTT no greater than 1.5 times ULN
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No documented hepatitis B infection
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No documented hepatitis C infection
Renal
- Creatinine clearance greater than 60 mL/min
Cardiovascular
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Ejection fraction greater than 45% by MUGA
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Hypertension (resting blood pressure greater than 140/90 mm Hg) must be controlled with standard anti-hypertensive therapy
Pulmonary
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No severe asthma
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DLCO/VA greater than 50% of predicted
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FEV_1 greater than 50% of predicted
Immunologic
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No autoimmune disease
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Peripheral CD3+ cell count greater than 300/mm^3 and stable on 4 successive determinations
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HIV negative
Other
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Not pregnant
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Negative pregnancy test
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Fertile patients must use effective contraception
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No other medical or psychiatric condition that would preclude study compliance
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No cognitive impairment or likelihood of developing cognitive impairment during study participation
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No need for palliative therapy
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No splenomegaly
PRIOR CONCURRENT THERAPY:
Biologic therapy
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More than 4 weeks since prior immunotherapy by cytokines, anti-tumor vaccines, or monoclonal antibody therapy prior to the initiation of peripheral CD3 count determination
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No prior allogeneic hematopoietic stem cell transplantation
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No other concurrent immunotherapy
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No other concurrent biologic agents (e.g., growth factors or monoclonal antibodies)
Chemotherapy
- No concurrent chemotherapy
Endocrine therapy
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No prior systemic corticosteroid therapy for more than 72 hours within the 2 weeks prior to initiation of peripheral CD3 cell count determination
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No concurrent chronic steroid therapy
Radiotherapy
- Not specified
Surgery
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No prior solid organ transplantation
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No prior splenectomy
Other
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More than 4 weeks since prior cytotoxic therapy prior to the initiation of peripheral CD3 cell count determination
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No concurrent cytotoxic therapy
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No concurrent immunosuppressive therapy
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No concurrent medications for the treatment of hypertension
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No concurrent chronic asthma medications
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No concurrent chronic anticoagulants (e.g., high-dose warfarin, heparin, or aspirin)
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Low-dose oral warfarin allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland | United States | 20892-1182 |
| 2 | NCI - Center for Cancer Research | Bethesda | Maryland | United States | 20892 |
| 3 | Methodist Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
- National Cancer Institute (NCI)
Investigators
- Study Chair: Claude Sportes, MD, National Cancer Institute (NCI)
- : Ronald E. Gress, MD, NCI - Experimental Transplantation and Immunology Branch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 030152
- 03-C-0152I
- CDR0000304451
- NCT00059059