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

November 27, 2017 updated by: Masonic Cancer Center, University of Minnesota

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Daniel J. Weisdorf, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

October 7, 2003

First Posted (Estimate)

October 8, 2003

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999LS080
  • MT1999-19 (Other Identifier: Blood and Marrow Transplantation Program)
  • NCI-G00-1807

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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