Full Text View
Tabular View
No Study Results Posted
Related Studies
Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: 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
Biological: aldesleukin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)

Resource links provided by NLM:


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

Additional Information:
No publications provided

Study ID Numbers: CDR0000064671, UW-26-245-B, NCI-V96-0848
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002746     History of Changes
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

Additional relevant MeSH terms:
Anti-Infective Agents
Precancerous Conditions
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia
Preleukemia
Pathologic Processes
Anti-Retroviral Agents
Sensory System Agents
Syndrome
Therapeutic Uses
Analgesics
Disease
Neoplasms by Histologic Type
Anti-HIV Agents
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Antiviral Agents
Pharmacologic Actions
Neoplasms
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 11, 2009