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Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

Primary Purpose

Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carmustine
cyclophosphamide
cytarabine
dexamethasone
etoposide
filgrastim
mitoxantrone hydrochloride
retrovirus vector LN
in vitro-treated peripheral blood stem cell transplantation
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Intermediate or high grade non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) Chemotherapy sensitive, initial partial remission OR Relapse after initial complete or partial remission Low grade NHL eligible provided progression following initial partial or complete remission Ineligible for ongoing allogeneic marrow donor transplant protocols or elected not to participate in such protocols No chemotherapy resistant NHL or HD NOTE: 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 70 Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST less than 2.5 times upper limit of normal (ULN) Bilirubin less than 2.5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: Resting LVEF at least 40% No unstable ischemic heart disease Pulmonary: Spirometry and DLCO greater than 50% predicted Other: No active uncontrolled infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2000
    Last Updated
    November 27, 2017
    Sponsor
    Masonic Cancer Center, University of Minnesota
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005998
    Brief Title
    Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
    Official Title
    Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn because study never enrolled patients
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    March 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Masonic Cancer Center, University of Minnesota
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation using specially treated stem cells may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
    Detailed Description
    OBJECTIVES: Determine whether priming with hematopoietic cytokines and chemotherapy increases the yield of hematopoietic progenitors in peripheral blood stem cells (PBSC) in patients with non-Hodgkin's lymphoma or Hodgkin's disease undergoing autologous PBSC transplantation. Determine whether in vitro studies can predict the transduction efficiency of early and late engrafting hematopoietic stem cells in this patient population undergoing this treatment. Determine whether in vitro transduction of a graft product stable long term transduction of marrow cells in these patients after autologous transplantation. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily on days 1-7. Peripheral blood stem cells (PBSC) are collected on days 5-7. Patients receive cyclophosphamide IV over 2 hours, mitoxantrone IV, and cytarabine IV every 12 hours for 2 doses on day 10, and dexamethasone every 12 hours for 4 doses on days 10 and 11. Patients receive G-CSF SC for the next 10-20 days. Additional PBSC are collected on days 25-28 or 29. Beginning 7 days before PBSC transplantation, patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation (TBI) twice daily on days -4 to -1. Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over 1 hour on days -6, and etoposide IV over 1 hour every 12 hours on days -6 to -4. Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery. Patients are followed at 1, 3, 6, 9, 12, 18, and 24 months and then annually thereafter. PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 12-15 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    recurrent adult Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    carmustine
    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    cytarabine
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    filgrastim
    Intervention Type
    Drug
    Intervention Name(s)
    mitoxantrone hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    retrovirus vector LN
    Intervention Type
    Procedure
    Intervention Name(s)
    in vitro-treated peripheral blood stem cell transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    peripheral blood stem cell transplantation
    Intervention Type
    Procedure
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Intermediate or high grade non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) Chemotherapy sensitive, initial partial remission OR Relapse after initial complete or partial remission Low grade NHL eligible provided progression following initial partial or complete remission Ineligible for ongoing allogeneic marrow donor transplant protocols or elected not to participate in such protocols No chemotherapy resistant NHL or HD NOTE: 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 70 Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST less than 2.5 times upper limit of normal (ULN) Bilirubin less than 2.5 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: Resting LVEF at least 40% No unstable ischemic heart disease Pulmonary: Spirometry and DLCO greater than 50% predicted Other: No active uncontrolled infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel J. Weisdorf, MD
    Organizational Affiliation
    Masonic Cancer Center, University of Minnesota
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease

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