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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00058045
Enrollment
1
Registered
2003-04-09
Start date
2002-08-31
Completion date
Unknown
Last updated
2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphoma

Brief 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.

Detailed description

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.

Interventions

BIOLOGICALaldesleukin

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026