Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003960
First received: November 1, 1999
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: busulfan
Drug: cyclophosphamide
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Estimated Enrollment: 36
Study Start Date: April 1998
Study Completion Date: September 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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

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 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.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after 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 more than 2 episodes of active CNS disease

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 the 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, or 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

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003960

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, South Carolina
Center for Cancer Treatment and Research
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Paul V. O'Donnell, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003960     History of Changes
Other Study ID Numbers: J9828 CDR0000067159, P30CA006973, JHOC-98032006, JHOC-J9828, NCI-G99-1543
Study First Received: November 1, 1999
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
refractory multiple myeloma
chronic phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
acute undifferentiated leukemia
secondary acute myeloid leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes

Additional relevant MeSH terms:
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Busulfan
Cyclophosphamide
Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Alkylating Agents

ClinicalTrials.gov processed this record on August 28, 2014