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

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