ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003960
  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 II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Multiple Myeloma   

Drug Information available for:   Cyclophosphamide    Methylprednisolone    Busulfan   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   36
Study Start Date:   April 1998

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

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Paul V. O'Donnell, MD, PhD     Fred Hutchinson Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067159, JHOC-98032006, JHOC-J9828, NCI-G99-1543
First Received:   November 1, 1999
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00003960
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Leukemia, Lymphoid
Chronic myelogenous leukemia
Precancerous Conditions
Hematologic Neoplasms
Methylprednisolone
Refractory anemia
Blood Protein Disorders
Prednisolone acetate
Paraproteinemias
Cyclophosphamide
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Hemostatic Disorders
Acute lymphoblastic leukemia, adult
Leukemia
Preleukemia
Anemia, Refractory
Hemorrhagic Disorders
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Methylprednisolone Hemisuccinate
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myelodysplasia
Myelodysplastic Syndromes

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neuroprotective Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Cardiovascular Diseases
Alkylating Agents
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Autonomic Agents
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers