Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Asparaginase; Cytarabine; Gemtuzumab; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of primary acute myeloid leukemia (AML) or myelodysplastic syndromes

• Relapsed (remission duration less than 1 year) OR

• Failed induction (failed to achieve an initial complete response)

• Patients with AML as a second malignant neoplasm allowed provided no other prior therapy for AML

• M2 or M3 bone marrow aspirate at time of study entry

• No Fanconi's anemia

• No known CNS leukemia

PATIENT CHARACTERISTICS:

Age:

• 21 and under

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 times normal

• AST or ALT less than 2.5 times upper limit of normal

• No history of veno-occlusive disease of the liver defined as weight increase of more than 5% over baseline and serum bilirubin greater than 5 mg/dL within 20 days after receipt of chemotherapy

Renal:

• Creatinine no greater than 1.5 times normal OR

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR

• Equivalent GFR by institutional normal range

Cardiovascular:

• Shortening fraction more than 27% by echocardiogram or normal for institution OR

• Ejection fraction more than 50% by MUGA

Other:

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 180 days since prior hematopoietic stem cell transplantation

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified