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Combination Chemotherapy Plus Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
This study has been completed.
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002697
  Purpose

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 Intervention Phase
Lymphoma
Drug: carboplatin
Drug: etoposide
Drug: filgrastim
Drug: ifosfamide
Drug: sargramostim
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Phase II

MedlinePlus related topics: Bone Marrow Transplantation Cancer Lymphoma
Drug Information available for: Ifosfamide Carboplatin Filgrastim Etoposide Sargramostim Granulocyte-macrophage colony-stimulating factor Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: HIGH DOSE CHEMORADIOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR PATIENTS WITH PRIMARY REFRACTORY, RELAPSED AND POOR PROGNOSIS NON-HODGKIN'S LYMPHOMA

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1995
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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.

PATIENT CHARACTERISTICS:

Age:

  • Physiologic 18 to 65

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • 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

Renal:

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

Cardiovascular:

  • 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

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002697

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000064483, MSKCC-95072, NCI-V95-0784
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002697  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Carboplatin
Etoposide phosphate
Lymphoma, large-cell, immunoblastic
Recurrence
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Ifosfamide
Leukemia, Lymphocytic, Chronic, B-Cell
B-cell lymphomas
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma
Follicular lymphoma
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009