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Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004145
  Purpose

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. Sometimes the transplanted cells are rejected by the body's normal tissues. Antithymocyte globulin may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus biological therapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: peripheral blood stem cell transplantation
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Anemia    Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

ChemIDplus related topics:   Cyclophosphamide    Fludarabine    Fludarabine monophosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies

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

Study Start Date:   November 1998

Detailed Description:

OBJECTIVES: I. Determine the effect of nonmyeloablative chemotherapy followed by allogeneic peripheral blood stem cell transplantation on hematopoietic recovery in patients with hematologic malignancies. II. Determine the toxicities of this regimen in these patients. III. Determine the frequency of mixed hematopoietic chimerism in these patients after this therapy. IV. Determine the efficacy and toxicity of donor leukocyte infusions at relapse in these patients. V. Determine the response rates and survival of these patients after this therapy. VI. Determine the immune reconstitution of patients undergoing this therapy.

OUTLINE: Patients receive fludarabine IV over 30 minutes on days -9 to -5, cyclophosphamide IV over 1 hour on day -5, and antithymocyte globulin IV over 10 hours on days -5 to -2. Allogeneic peripheral blood stem cells are infused on day 0. Patients who achieve complete remission (CR) and then relapse or patients who achieve less than a CR before day 60 receive donor leukocyte infusions (DLI) over 30 minutes. DLI are repeated as necessary for persistent disease. Patients are followed at 1, 3, and 6 months, then at 1 and 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy for which there is no standard curative therapy, including, but not limited to: Low grade non-Hodgkin's lymphoma (NHL) Mantle cell lymphoma Chronic lymphocytic leukemia (stage II-IV) Myelodysplastic syndrome, including: Refractory anemia (RA) with ringed sideroblasts RA with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Multiple myeloma OR Histologically proven hematologic malignancy that has failed 1 prior therapy OR is at high risk for relapse, including, but not limited to: Intermediate grade NHL High grade NHL Hodgkin's disease Acute lymphoblastic lymphoma Acute myelogenous leukemia OR Histologically proven chronic myelogenous leukemia in chronic or accelerated phase, with the following risk factors that preclude eligibility for standard allogeneic peripheral blood stem cell transplantation: Older age Poor performance status Healthy, partially related HLA 5/6 or 6/6 serologic match donor available A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 18 to 60 or physiologic 70 Performance status: Karnofsky 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times normal No active hepatitis Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: Ejection fraction greater than 45% OR Cardiac clearance Pulmonary: DLCO at least 50% predicted Other: No active infection HIV-1, HIV-2, and HTLV-1 negative Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified 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: NCT00004145

Locations
United States, Illinois
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637-1470

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Todd M. Zimmerman, MD     University of Chicago    
  More Information

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

Study ID Numbers:   CDR0000067376, UCCRC-9581, UCCRC-CTRC-9852, NCI-G99-1618
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004145
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
refractory plasma cell neoplasm  
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  
stage II chronic lymphocytic leukemia  
stage III chronic lymphocytic leukemia  
stage IV chronic lymphocytic leukemia  
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
refractory chronic lymphocytic leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma

Study placed in the following topic categories:
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Refractory anemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Preleukemia
Anemia, Refractory
Hemorrhagic Disorders
Multiple myeloma
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Multiple Myeloma
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Fludarabine
Leukemia, B-Cell

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 05, 2008




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