Interleukin-2 in Treating Patients With Myelodysplastic Syndrome - Full Text View

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 Neoplasms	Biological: aldesleukin	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Myelodysplastic Syndromes

Drug Information available for: Aldesleukin

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Myelodysplastic/myeloproliferative Disease Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive

U.S. FDA Resources

Further study details as provided by University of Washington:


Enrollment:	24
Study Start Date:	January 1996
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

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 (Child, Adult, Senior)
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

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 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


Responsible Party:	University of Washington
ClinicalTrials.gov Identifier:	NCT00002746 History of Changes
Other Study ID Numbers:	CDR0000064671 UW-26-245-B NCI-V96-0848
Study First Received:	November 1, 1999
Last Updated:	December 12, 2012
Health Authority:	United States: Federal Government

Keywords provided by University of Washington:


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, BCR-ABL1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable childhood myelodysplastic syndromes

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 23, 2016