Interleukin-7 in Treating Patients With Refractory Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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A Phase I Study of Subcutaneous CYT 99 007 (Interleukin-7) in Patients With Refractory Non Hematologic Malignancy

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: recombinant interleukin-7


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignancy meeting both of the following criteria: No known curative therapy Failed standard therapy, defined as either lack of response OR disease progression (i.e., at least 25% increase in disease or new disease) Measurable or evaluable disease No hematopoietic malignancies No primary carcinoma of the lung PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy At least 3 months Hematopoietic Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 No proliferative hematologic disease Hepatic AST and ALT less than 3 times upper limit of normal (ULN) PT/PTT no greater than 1.5 times ULN No documented hepatitis B infection No documented hepatitis C infection Renal Creatinine clearance greater than 60 mL/min Cardiovascular Ejection fraction greater than 45% by MUGA Hypertension (resting blood pressure greater than 140/90 mm Hg) must be controlled with standard anti-hypertensive therapy Pulmonary No severe asthma DLCO/VA greater than 50% of predicted FEV_1 greater than 50% of predicted Immunologic No autoimmune disease Peripheral CD3+ cell count greater than 300/mm^3 and stable on 4 successive determinations HIV negative Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other medical or psychiatric condition that would preclude study compliance No cognitive impairment or likelihood of developing cognitive impairment during study participation No need for palliative therapy No splenomegaly PRIOR CONCURRENT THERAPY: Biologic therapy 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 No prior allogeneic hematopoietic stem cell transplantation No other concurrent immunotherapy No other concurrent biologic agents (e.g., growth factors or monoclonal antibodies) Chemotherapy No concurrent chemotherapy Endocrine therapy No prior systemic corticosteroid therapy for more than 72 hours within the 2 weeks prior to initiation of peripheral CD3 cell count determination No concurrent chronic steroid therapy Radiotherapy Not specified Surgery No prior solid organ transplantation No prior splenectomy Other More than 4 weeks since prior cytotoxic therapy prior to the initiation of peripheral CD3 cell count determination No concurrent cytotoxic therapy No concurrent immunosuppressive therapy No concurrent medications for the treatment of hypertension No concurrent chronic asthma medications No concurrent chronic anticoagulants (e.g., high-dose warfarin, heparin, or aspirin) Low-dose oral warfarin allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interleukin-7|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific