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Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005092
  Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.


Condition Intervention Phase
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: cyclophosphamide
Drug: psoralen
Drug: thiotepa
Procedure: allogeneic bone marrow transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Fungal Infections    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

Drug Information available for:   Cyclophosphamide    Thiotepa    Ficusin    Amotosalen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation

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

Study Start Date:   March 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of T-cells photochemically treated with psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with hematologic malignancies or bone marrow failure myelodysplastic syndrome. II. Assess the toxicity of this treatment in these patients. III. Evaluate this regimen in terms of prevention of graft versus host disease and control of malignancy in these patients.

OUTLINE: This is a dose escalation, multicenter study of T-cells photochemically treated with psoralen and ultraviolet A. Patients receive thiotepa IV over 2 hours on day 1, cyclophosphamide IV over 2 hours on days 2 and 3, and whole body radiotherapy on days 5-8. Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9. Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients are followed for 100 days.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Hematologic malignancy, including acute myeloid or lymphoid leukemia of any FAB subtype, not in remission with chemotherapy or requiring bone marrow transplant OR Chronic myeloid leukemia, advanced beyond first chronic phase OR Myelodysplasia, including secondary to prior chemotherapy, with: Granulocyte count less than 500/mm3 OR Platelet count less than 50,000/mm3 OR High risk cytogenetic abnormalities such as +8, -7, -5, or 11q23 OR Intermediate or high grade lymphoma without response to initial therapy or in relapse OR Multiple myeloma without response to initial therapy or in relapse OR Stage IV low grade lymphoma or chronic lymphocytic leukemia not achieving remission with 2 regimens No aplastic anemia Related haploidentical donor (1-3 HLA-A, B, and/or DR mismatch) for collection of stem cells and whole blood T-cells required

PATIENT CHARACTERISTICS: Age: 6 months to 49 years Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 3 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 45% No symptoms or active treatment of left ventricular failure Pulmonary: Corrected DLCO at least 50% Other: No acute viral, bacterial, or fungal infection No prior transfusion associated graft versus host disease No other medical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy or interferon alfa and recovered No prior autologous or allogeneic progenitor cell transplant Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005092

Locations
United States, Illinois
University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612
United States, Missouri
Washington University Barnard Cancer Center    
      Saint Louis, Missouri, United States, 63110
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     James Gajewski, MD     M.D. Anderson Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000067734, MDA-DM-98283, NCI-G00-1742
First Received:   April 6, 2000
Last Updated:   November 16, 2008
ClinicalTrials.gov Identifier:   NCT00005092
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent childhood acute lymphoblastic leukemia  
recurrent adult Hodgkin lymphoma  
stage III cutaneous T-cell non-Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
refractory multiple myeloma  
stage III multiple myeloma  
stage III childhood lymphoblastic lymphoma  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood lymphoblastic lymphoma  
stage III chronic lymphocytic leukemia  
stage IV chronic lymphocytic leukemia  
recurrent childhood acute myeloid leukemia  
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
adult acute monoblastic leukemia and acute monocytic leukemia (M5)
childhood acute monoblastic leukemia and acute monocytic leukemia (M5)
T-cell large granular lymphocyte leukemia
B-cell chronic lymphocytic leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Di Guglielmo's syndrome
Lymphoma, large-cell, immunoblastic
Mycoses
Preleukemia
Hemorrhagic Disorders
Leukemia, Prolymphocytic
Multiple myeloma
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Lymphoma, Large-Cell, Anaplastic
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, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute promyelocytic leukemia
Acute myelogenous leukemia

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

ClinicalTrials.gov processed this record on December 03, 2008




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