interleukin-2 and stem cell factor in treating patients with aids or aids-related cancer

Conditions: Lymphoma

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill cancer cells. stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy. purpose: phase i trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have aids or aids-related cancer.

objectives: * determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with aids or aids-related malignancies. * determine the immune status of patients treated with this regimen. outline: this is a multicenter, dose-escalation study of stem cell factor. patients receive interleukin-2 (il-2) subcutaneously (sc) six days a week and stem cell factor sc three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, an additional cohort of 3 patients receives treatment at the mtd. patients are followed every 2 weeks for 1 month. projected accrual: a total of 3-18 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of hiv-1 by elisa, western blot, polymerase chain reaction, or other documentation * must have had 1 of the following aids-defining illnesses: * opportunistic infection * opportunistic malignancy (excluding cns involvement) * cd4 t-cell count less than 200/mm\^3 (but currently greater than 20/mm\^3) * receiving antiretroviral therapy * no concurrent kaposi's sarcoma * prior kaposi's sarcoma in complete response allowed patient characteristics: age * 18 and over performance status * karnofsky 80-100% life expectancy * not specified hematopoietic * absolute granulocyte count greater than 1,000/mm\^3\* * hemoglobin at least 10 g/dl\* * platelet count greater than 50,000/mm\^3\* note: \*transfusions and growth factors allowed in order to increase or maintain counts hepatic * no major hepatic dysfunction evidenced by encephalopathy, ascites, or varices * bilirubin no greater than 2 mg/dl * inr no greater than 1.5 renal * not specified cardiovascular * no prior angioedema * no uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmhg) * no unstable angina * no new york heart association class iii or iv heart disease * no congestive heart failure * no coronary angioplasty within the past 6 months * no myocardial infarction within the past 6 months * no uncontrolled atrial or ventricular cardiac arrhythmia pulmonary * no history of seasonal or recurrent asthma within the past 10 years * no concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection immunologic * no prior positive allergy test (skin or radioallergosorbent test) for insect venoms * no known allergy to e. coli-derived products * no prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm * drug allergies manifested solely by rash and/or urticaria allowed * no recurrent urticaria (isolated episode of urticaria allowed) * no other active uncontrolled infection (including one with current symptoms of bronchoconstriction) * no fever of 38.2° c or higher * fevers due to b symptoms allowed other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no prior or concurrent cns malignancy * no poorly controlled diabetes * no other significant nonmalignant disease * no other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy) prior concurrent therapy: biologic therapy * see hematopoietic in patient characteristics * no prior stem cell factor * no concurrent interleukin-11 for thrombocytopenia chemotherapy * no concurrent chemotherapy for malignancy endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * no concurrent enrollment on any other protocol utilizing an investigational drug * no concurrent beta adrenergic blocking agents

Keywords: aids-related peripheral/systemic lymphoma