Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer (NCT00058045) | Clinical Trial Compass
CompletedPhase 1
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
United States1 participantsStarted 2002-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 concurre…