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Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
Sponsored by: University of Washington
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002746
  Purpose

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.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: aldesleukin
Phase I

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Aldesleukin Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: January 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002746

Locations
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
University of Washington
Investigators
Study Chair: John A. Thompson, MD Seattle Cancer Care Alliance
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000064671, UW-26-245-B, NCI-V96-0848
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002746  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
childhood myelodysplastic syndromes

Study placed in the following topic categories:
Myelodysplastic syndromes
Chronic myelogenous leukemia
Precancerous Conditions
Chronic myelomonocytic leukemia
Refractory anemia
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplasia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia
Preleukemia
Aldesleukin
Anemia, Refractory
Interleukin-2
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Disease
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009