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Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
This study has been completed.
First Received: April 7, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Roswell Park Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058045
  Purpose

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
Lymphoma
Biological: aldesleukin
Biological: recombinant human stem cell factor
Phase I

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: August 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058045

Locations
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
Investigators
Study Chair: Zale P. Bernstein, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000285694, RPCI-RP-9911
Study First Received: April 7, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00058045     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related peripheral/systemic lymphoma

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Anti-Retroviral Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Retroviridae Infections
Lymphoma
RNA Virus Infections
Anti-HIV Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Lymphatic Diseases
Neoplasms
Aldesleukin
HIV Infections
Interleukin-2
Analgesics, Non-Narcotic
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009