Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.

PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of New South Wales
• Treatments: Alemtuzumab; Arsenic Trioxide; Azacitidine; Busulfan; Clofarabine; Cytarabine; Daunorubicin; Fludarabine; Fludarabine phosphate; Gemtuzumab; Melphalan; Tipifarnib

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Acute myeloid leukemia (AML) meeting the following criteria:

• De novo or secondary AML

• No acute promyelocytic leukemia

• High-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)

• No blast transformation of chronic myeloid leukemia

• Patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial MRC-AMLI5

PATIENT CHARACTERISTICS:

• Not pregnant or nursing

• AST and ALT ≤ 2 times upper limit of normal (ULN) (for patients receiving gemtuzumab ozogamicin)

• Bilirubin ≤ 2 times ULN (for patients receiving gemtuzumab ozogamicin)

• Creatinine normal (for patients receiving clofarabine)

• No other concurrent active malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

• No prior cytotoxic chemotherapy for AML

• Hydroxyurea or similar low-dose therapy to control WBC count prior to initiation of intensive therapy allowed

• No concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)