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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00058045
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : January 31, 2013
Information provided by:

April 7, 2003
April 9, 2003
January 31, 2013
August 2002
November 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00058045 on ClinicalTrials.gov Archive Site
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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

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.


  • 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.

Phase 1
Primary Purpose: Treatment
  • Biological: aldesleukin
  • Biological: recombinant human stem cell factor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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November 2003   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified


  • 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


  • No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices
  • Bilirubin no greater than 2 mg/dL
  • INR no greater than 1.5


  • Not specified


  • 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


  • 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


  • 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


  • 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)


Biologic therapy

  • See Hematopoietic in Patient Characteristics
  • No prior stem cell factor
  • No concurrent interleukin-11 for thrombocytopenia


  • No concurrent chemotherapy for malignancy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No concurrent enrollment on any other protocol utilizing an investigational drug
  • No concurrent beta adrenergic blocking agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
RP 99-11
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Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Zale P. Bernstein, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP