Clinical Trial: Rituximab and Carmustine, Cytarabine, Etoposide, and Melphalan Followed By Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: University of Nebraska
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult non-Hodgkin's lymphoma
 Drug: carmustine
 Drug: cytarabine
 Drug: etoposide
 Drug: melphalan
 Drug: rituximab
 Procedure: antibody therapy
 Procedure: autologous bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: high-dose chemotherapy
 Procedure: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Rituximab and Carmustine, Cytarabine, Etoposide, and Melphalan Followed By Autologous Hematopoietic Stem Cell Transplantation in Patients With CD20-Positive B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

  • Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma.
  • Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the event-free survival of patients treated with this regimen.
  • Determine the toxicity profile of this regimen in these patients.

OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest.

Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0.

Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks.

Patients are followed at day 100, at 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-Hodgkin's lymphoma
  • Any B cell
  • CD20-positive disease
  • Failed prior primary induction therapy
  • Meets 1 of the following criteria:
  • Chemotherapy-refractory disease
  • Received at least 3 prior chemotherapy regimens
  • Mantle cell lymphoma
  • Eligible for transplantation
  • No history of T-cell lymphoma

PATIENT CHARACTERISTICS: Age

  • 19 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count > 50,000/mm^3*
  • Hemoglobin > 9.0 g/dL* NOTE: *Unless due to lymphomatous involvement of the bone marrow

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant or nursing
  • Fertile patients must use 2 methods of effective contraception
  • No other concurrent serious disease or condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Location Information


Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

Study chairs or principal investigators

Julie M. Vose, MD,  Study Chair,  University of Nebraska   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000357306; UNMC-06302
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080886
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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