Clinical trial · Interventional
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
NCT00058045CI-TRIAL-00009235completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| recombinant human stem cell factor | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.