Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
adult acute myeloid leukemia in remission chronic phase chronic myelogenous leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphocytic leukemia adult acute lymphocytic leukemia in remission refractory chronic myelogenous leukemia	Drug: cyclophosphamide  Drug: cytarabine  Drug: etoposide  Drug: filgrastim  Drug: idarubicin  Drug: interferon alfa	Phase II

Further Study Details: 

OBJECTIVES: I. Determine safety and toxicity of induction and transplant regimens in patients with chronic myelogenous leukemia or high risk acute leukemia.

II. Determine efficacy of collecting peripheral blood stem cells (PBSC) during early hematopoietic recovery from intensive chemotherapy as a means for in vivo enrichment for cytogenetically normal progenitor cells in this patient population.

III. Correlate cytogenetic and molecular responses in the peripheral blood and bone marrow with clinical response, time to progression, and survival in these patients at several timepoints before and after myelosuppressive and myeloablative therapy.

PROTOCOL OUTLINE: This is a mulitcenter study. Patients are stratified according to disease (chronic myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia).

Patients receive cytarabine IV over 4 hours, then etoposide IV over 1.5-2 hours, then idarubicin IV over 5-10 minutes on days 1, 3, and 5. Filgrastim (G-CSF) is administered subcutaneously (SQ) daily beginning on day 2 and continuing until blood counts recover.

Chronic myelogenous leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and a peripheral blood sample contains greater than 50% cytogenetically normal cells, patients receive a second induction course followed by apheresis. Patients with less than 50% cytogenetically normal cells are also considered for a second induction course. Patients with no response or progressive disease are removed from the study.

Acute leukemia: On day 14 following chemotherapy, if bone marrow biopsy shows less than 20% cellularity and the peripheral blood sample shows 100% cytogenetically normal cells, patients receive a second induction course followed by apheresis. Patients with high risk disease in first remission at time of study entry are apheresed during recovery from first course of induction therapy and second course may be omitted.

Patients receive second induction course followed by G-CSF as after first induction course. Once blood counts recover, patients undergo harvest of peripheral blood stem cells (PBSC). Patients also undergo bone marrow stem cell collection in case of failure of PBSC transplantation (PBSCT).

Patients receive the following conditioning regimen: total body irradiation twice a day on days -8 to -5; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 2 hours on day -2. PBSCT is conducted on day 0. G-CSF SQ is administered beginning on day 1 and continues until blood counts recover.

Patients receive maintenance therapy with interferon alfa SQ 3 times a week for 12 months.

Patients are followed weekly for 3 months, then monthly until death.

PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study.

Ages Eligible for Study:  18 Years   -   60 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• One of the following hematologic conditions: Chronic phase or advanced chronic myelogenous leukemia; Acute lymphoblastic leukemia: relapsed; in second remission or later; in first remission with unfavorable prognostic features; Acute myelogenous leukemia: in second remission or later; in first remission with high risk features
• Detectable clonal cytogenetic or molecular abnormality at time of diagnosis
• Not eligible for allogenic bone marrow transplant

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics
• Chemotherapy: Prior chemotherapy allowed
• Endocrine therapy: Not specified
• Radiotherapy: Prior radiotherapy allowed
• Surgery: Prior surgery allowed

--Patient Characteristics--

• Age: 18 to 60
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin less than 2 times upper limit of normal (ULN); SGOT/SGPT less than 2 times ULN
• Renal: Creatinine clearance greater than 60 mL/min
• Cardiovascular: Ejection fraction greater than 45%
• Pulmonary: DLCO greater than 60%; FEV1 greater than 60%
• Other: No serious underlying medical condition that would preclude study; Not pregnant or nursing; No cerebellar dysfunction

Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Study chairs or principal investigators

Jane N. Winter,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067584; NU-L94H2; NCI-G00-1702; LUMC-5892
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004905
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08