Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Countries
United States