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Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002697
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy and peripheral stem cell transplantation may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy plus radiation therapy followed by peripheral stem cell transplantation in patients with refractory or recurrent non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Biological: sargramostim Drug: carboplatin Drug: etoposide Drug: ifosfamide Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 1995
Primary Completion Date : June 2003
Study Completion Date : June 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • One of the following diagnoses:

    • Histologically proven recurrent non-Hodgkin's lymphoma

      • Previously in complete remission (CR)
    • Refractory or recurrent intermediate-grade lymphoma (IGL) or high-grade immunoblastic lymphoma (IBL) meeting 1 of the following conditions:

      • In partial remission (PR) or CR to and currently enrolled on the MSKCC standard dose salvage regimen with ifosfamide, carboplatin, and etoposide (ICE)
      • In PR or CR after 1-2 other salvage chemotherapy regimens (e.g., 3 courses of dexamethasone, high-dose cytarabine, and cisplatin (DHAP); 2 courses of cyclophosphamide, mechlorethamine, vincristine, procarbazine, and prednisone (C-MOPP))

        • No prior ifosfamide
    • Low-grade lymphoma

      • In second or greater remission or chemosensitive relapse
      • No HLA identical sibling donor available
    • IGL or IBL

      • In first CR
      • Poor prognosis, defined by age-adjusted international index of 3 or 4 based on lactic dehydrogenase, number of extranodal sites, stage, and performance status
  • Adequate bone marrow cellularity
  • No lymphoblastic or small noncleaved cell lymphoma
  • Ineligible for total body irradiation (TBI) phase of study if prior radiotherapy dose precludes the use of TBI 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.



  • Physiologic 18 to 65

Performance status:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL (if no history of Gilbert's disease)
  • No chronic active or persistent hepatitis
  • Hepatitis B positivity allowed provided that the following conditions are met:

    • Bilirubin same as above*
    • SGPT no greater than 500 IU/L*
    • Alkaline phosphatase no greater than 2 times normal* NOTE: * In the absence of liver involvement by lymphoma


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No history of chronic renal insufficiency


  • LVEF at least 50% by echocardiogram or MUGA scan
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No arrhythmia other than chronic atrial fibrillation


  • DLCO at least 50% predicted (corrected for hemoglobin and alveolar ventilation)


  • HIV negative
  • No uncontrolled infection
  • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002697

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Study Chair: Craig Moskowitz, MD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00002697     History of Changes
Other Study ID Numbers: 95-072
CDR0000064483 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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 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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents