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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002697
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013
  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
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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: HIGH DOSE CHEMORADIOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR PATIENTS WITH PRIMARY REFRACTORY, RELAPSED AND POOR PROGNOSIS NON-HODGKIN'S LYMPHOMA

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: September 1995
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002697     History of Changes
Other Study ID Numbers: 95-072, CDR0000064483, NCI-V95-0784
Study First Received: November 1, 1999
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

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
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 30, 2014