RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.

Condition	Treatment or Intervention	Phase
Chronic Myelogenous Leukemia Graft vs Host Disease Philadelphia chromosome Myeloid Leukemia Refractory Anemia Chronic Myelomonocytic Leukemia	Drug: cladribine  Drug: cyclosporine  Drug: cytarabine  Drug: filgrastim  Drug: fludarabine  Drug: idarubicin  Drug: methylprednisolone	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy.

II. Determine the engraftment kinetics and degree of chimerism achievable.

PROTOCOL OUTLINE: The trial will have 2 patient groups.

Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms.

Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days.

Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4.

Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0.

For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methyprednisolone begins 5 days after infusion and is gradually tapered.

PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.

Ages Eligible for Study:  55 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Acute leukemia with poor risk cytogenetic features (-5,-7, +8) in first complete remission
• Poor risk myelodysplasia
• Refractory anemia with excess blasts (RAEB); RAEB in transformation (RAEB-T); Chronic myelomonocytic leukemia (CMML); Chronic myelogenous leukemia (CML) in late chronic phase
• Acute leukemia with greater than first complete remission or transformed CML or CMML

--Prior/Concurrent Therapy--

• Not specified

--Patient Characteristics--

• Age: 55 to 65; 65 to 70 (at the discretion of study chairperson on basis of performance status); 55 and under (if declined for conventional high dose chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50, FEV1, FVC, or DLCO less than 50%, abnormal LFTs)
• Performance status: Zubrod less than 2
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin less than 3 mg/dL
• Renal: Serum creatinine less than 2 mg/dL
• Cardiovascular: Ejection fraction greater than 40% per MUGA scan
• Pulmonary: Not specified
• Other: No active uncontrolled infection; HLA compatible donor capable of donating stem cells via apheresis

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Sergio Giralt,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000065035; MDA-DM-94078; NCI-G96-1001
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002833
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08