Clinical trial NCT00002746: Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
Official title: A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords: 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
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2003-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Seattle Cancer Care Alliance
name: John A. Thompson, MD
role: STUDY_CHAIR
References: