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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute Identifier:
First received: April 7, 2003
Last updated: January 30, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Biological: aldesleukin
Biological: recombinant human stem cell factor
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Enrollment: 1
Study Start Date: August 2002
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00058045

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Zale P. Bernstein, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided Identifier: NCT00058045     History of Changes
Other Study ID Numbers: RP 99-11, RPCI-RP-9911
Study First Received: April 7, 2003
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
AIDS-related peripheral/systemic lymphoma

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015