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Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Study NCT00002746   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
January 1996
 
 
 
Complete list of historical versions of study NCT00002746 on ClinicalTrials.gov Archive Site
 
 
 
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients with myelodysplastic syndrome.

OBJECTIVES:

  • Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).
  • Evaluate the hematologic effects of subcutaneous IL-2 in MDS.

OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially.

Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued.

PROJECTED ACCRUAL: Between 12-24 patients will be accrued.

Phase I
Interventional
Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
Biological: aldesleukin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
24
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML)
  • No patients with refractory anemia with excess blasts in transformation (RAEB-t)

PATIENT CHARACTERISTICS:

Age:

  • 15 and over

Performance status:

  • Karnofsky 70-100

Hematopoietic:

  • Platelet count greater than 20,000

Hepatic:

  • Bilirubin less than 1.6 mg/dL
  • SGOT less than 150 U/L

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension

Pulmonary:

  • No significant pleural effusion, dyspnea at rest or severe exertional dyspnea

Other:

  • No patients with nephrotic syndrome
  • No uncontrolled infections or active peptic ulcer disease
  • No serious intercurrent medical illness
  • Not pregnant or nursing
  • Adequate contraception required of all patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunosuppressive therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • At least 2 weeks since corticosteroid therapy
  • At least 4 weeks since other endocrine therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • Not specified
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002746
 
CDR0000064671, UW-26-245-B, NCI-V96-0848
University of Washington
 
Study Chair: John A. Thompson, MD Seattle Cancer Care Alliance
National Cancer Institute (NCI)
December 2003

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