Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant human stem cell factor


Participation Criteria
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Eligibility Criteria
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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

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: aldesleukin|nan|
|Biological: recombinant human stem cell factor|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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AIDS-related peripheral/systemic lymphoma