RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer.

Condition	Treatment or Intervention	Phase
untreated adult acute myeloid leukemia chronic phase chronic myelogenous leukemia Previously Treated Myelodysplastic Syndrome adult acute lymphoblastic leukemia in remission secondary myelodysplastic syndrome recurrent adult acute myeloid leukemia adult acute myeloid leukemia in remission de novo myelodysplastic syndrome refractory anemia with excess blasts in transformation refractory anemia with excess blasts recurrent adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia refractory plasma cell neoplasm	Drug: busulfan  Drug: cyclophosphamide  Drug: methylprednisolone	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the 1 year survival rate of patients with hematologic malignancies after treatment with allogeneic (HLA matched, unrelated) bone marrow transplantation following high dose chemotherapy.

PROTOCOL OUTLINE: Patients receive oral busulfan four times a day on days -8 to -5, cyclophosphamide IV over 1 hour on days -4 to -1, and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0. CD34+ stem cell augmented donor bone marrow is infused on day 0. Methylprednisolone is administered IV over 1 hour on days 5-16, and is then tapered. Patients are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Ages Eligible for Study:  19 Years   -   55 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Any of the following diagnoses: Chronic myelogenous leukemia (CML) in first chronic phase OR Myelodysplastic syndrome; Refractory anemia with excess blasts (RAEB) OR RAEB in transformation OR Secondary leukemias untreated or in complete remission 1 (CR1); Acute myeloid leukemia in complete remission 2 (CR2) OR Acute lymphocytic leukemia (ALL) in CR2 OR High risk acute leukemia in CR1 OR Ph+ ALL in CR1 or as consolidation following induction chemotherapy
• Must qualify for allogeneic bone marrow transplantation (BMT)
• No HLA matched, sibling donor for BMT available
• No current CNS disease
• No history of greater than 2 episodes of active CNS disease

--Prior/Concurrent Therapy--

• Biologic therapy: No prior autologous or allogeneic bone marrow transplantation; No prior transfusions from donor
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--Patient Characteristics--

• Age: 19 to 55
• Performance status: ECOG 0 or 1
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 2 mg/dL
• Renal: Creatinine no greater than 2 mg/dL
• Cardiovascular: LVEF at least 45%; No active congestive heart failure, arrhythmia, or angina pectoris; No myocardial infarction within past 12 months
• Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy)
• Other: No active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis, tuberculosis); HIV negative; Not pregnant; Fertile patients must use effective contraception; No concurrent debilitating medical or psychiatric illness that would preclude compliance; No prior malignancy except curatively treated skin cancer or carcinoma of the cervix

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231,  United States
South Carolina
      Center for Cancer Treatment and Research, Columbia,  South Carolina,  29203,  United States

Study chairs or principal investigators

Paul V. O'Donnell,  Study Chair,  Johns Hopkins Oncology Center   

Study ID Numbers:  CDR0000067159; JHOC-98032006; NCI-G99-1543; JHOC-J9828
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003960
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08