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

This study has been withdrawn prior to enrollment.

(Withdrawn because study never enrolled patients)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT00005998

First received: July 5, 2000

Last updated: October 9, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2000

Last Updated Date

October 9, 2012

Start Date ^ICMJE

January 2000

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00005998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: etoposide
Drug: filgrastim
Drug: mitoxantrone hydrochloride
Drug: retrovirus vector LN
Procedure: in vitro-treated peripheral blood stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

March 2003

Primary Completion Date

March 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00005998

Other Study ID Numbers ^ICMJE

1999LS080, MT1999-19, NCI-G00-1807

Has Data Monitoring Committee

Yes

Responsible Party

Masonic Cancer Center, University of Minnesota

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Daniel J. Weisdorf, MD

Masonic Cancer Center, University of Minnesota

Information Provided By

Masonic Cancer Center, University of Minnesota

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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