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A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)


Phase 1
15 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John A. Thompson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance

Authority:

United States: Federal Government

Study ID:

CDR0000064671

NCT ID:

NCT00002746

Start Date:

January 1996

Completion Date:

April 2004

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • 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
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

University of Washington Medical CenterSeattle, Washington  98195-6043