Clinical Trial: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: Swiss Institute for Applied Cancer Research
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult diffuse large cell lymphoma
adult diffuse mixed cell lymphoma
adult immunoblastic large cell lymphoma
anaplastic large cell lymphoma
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: hydrocortisone
 Drug: leucovorin calcium
 Drug: melphalan
 Drug: methotrexate
 Drug: methylprednisolone
 Drug: mitoxantrone
 Drug: prednisone
 Drug: vincristine
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Sequential High-Dose Chemotherapy With Autologous Peripheral Blood Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Patients at high risk of developing CNS disease receive prophylactic intrathecal chemotherapy. Patients may receive cytarabine, methotrexate, and hydrocortisone or methotrexate and hydrocortisone every 1-2 weeks for 6 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 4-5 years.

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
  • Diffuse large B-cell lymphoma
  • Primary mediastinal large B-cell lymphoma
  • Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type)
  • At least two of the following risk factors:
  • Stage III or IV
  • LDH greater than upper limit of normal (ULN)
  • ECOG 2, 3, or 4
  • No CNS involvement

PATIENT CHARACTERISTICS: Age:

  • 18 to 60

Performance status:

  • See Disease Characteristics
  • ECOG 0-4

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No hepatitis B or C
  • AST or ALT no greater than 2 times ULN*
  • Bilirubin no greater than 2.34 mg/dL* NOTE: *Unless due to tumor involvement

Renal:

  • Creatinine clearance at least 60 mL/min (unless due to tumor involvement)

Cardiovascular:

  • No significant heart failure
  • LVEF normal
  • No active angina pectoris
  • No myocardial infarction within the past 6 months
  • No major ventricular arrhythmia

Pulmonary:

  • No significant lung disorder

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy)

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • Not specified

Location Information


Austria
      Allgemeines Krankenhaus der Stadt Wien, Vienna,  A-1090,  Austria

Germany
      Dr. Horst-Schmidt-Kliniken, Wiesbaden,  D-65199,  Germany

Greece
      Saint Savvas Cancer Hospital of Athens, Athens,  11522,  Greece

Italy
      European Institute of Oncology, Milano,  20141,  Italy

Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  1011,  Switzerland

      Hopital Cantonal Universitaire de Geneve, Collonge-Bellerive,  CH-1245,  Switzerland

      Inselspital, Bern, Bern,  CH-3010,  Switzerland

      Kantonsspital - St. Gallen, St. Gallen,  CH-9007,  Switzerland

      Klinik Hirslanden, Zurich,  CH-8008,  Switzerland

      Oncology Institute of Southern Switzerland, Bellinzona,  CH-6500,  Switzerland

      Ratisches Kantons und Regionalspital, Chur,  CH-7000,  Switzerland

      Universitatsspital-Basel, Basel,  CH-4031,  Switzerland

Study chairs or principal investigators

Daniel C. Betticher, MD,  Study Chair,  Inselspital, Bern   

More Information

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

Study ID Numbers:  CDR0000066075; SWS-SAKK-38/97; EU-97037; NCT00003215
Record last reviewed:  March 2005
Last Updated:  March 10, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003215
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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

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