Interleukin-7 in Treating Patients With Refractory Solid Tumors

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