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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade non-Hodgkin's lymphoma.

Condition Intervention Phase
Biological: filgrastim
Drug: carboplatin
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: ifosfamide
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients >= 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkin's Lymphoma

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Treatment-related toxicity

Secondary Outcome Measures:
  • Efficacy in terms of 2-year disease-free survival

Study Start Date: January 1997
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • Assess the efficacy and toxic effects of carmustine/etoposide/melphalan (ICE) chemotherapy followed by peripheral blood progenitor cell transplantation in patients with refractory or relapsed intermediate grade non-Hodgkin's lymphoma.
  • Assess the ability of the ICE chemotherapy regimen, in conjunction with filgrastim, to mobilize peripheral blood stem cells.

OUTLINE: This is a descriptive pilot study.

Patients receive 3 cycles of induction chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). Each cycle is given at least 14 days apart. Patients receive etoposide IV on days 1 through 3. Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV over 24 hours on day 2.

During cycles 1 and 2, patients receive filgrastim (G-CSF) SC every 6 hours beginning on day 1 and continuing until the desired absolute neutrophil count (ANC) is attained.

Patients receive at least 24 hours of rest before PBPC infusion on day 0.

Following cycle 3, G-CSF is given SC beginning on day 6 and continuing until completion of PBPC collection. However, bone marrow will be harvested if an insufficient number of stem cells are collected after 5 leukaphereses.

Patients with residual disease limited to 2 sites receive radiation therapy twice a day within 2 weeks prior to high dose BEAM chemotherapy with carmustine, etoposide, cytarabine, and melphalan.

Patients receive carmustine IV on day -7. Etoposide and cytarabine are given IV every 12 hours on days -6 through -3. Melphalan is given IV on day -2.

G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC is attained. If ANC is attenuated on day 21, patients undergo a repeat bone marrow biopsy and receive filgrastim SC.

Patients are followed for 2 years posttransplant, then for 3 to 5 years at 4 month intervals and every 6 months following the fifth posttransplant.

PROJECTED ACCRUAL: This study will accrue 30 patients for the duration of 2 years.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Primary refractory intermediate grade non-Hodgkin's lymphoma (NHL) OR
  • Untreated relapsed intermediate grade NHL with no more than 1 extranodal site of disease
  • Biopsy proven relapse of diffuse large cell, diffuse mixed cell, diffuse small cleaved cell (excluding mantle cell lymphoma), follicular large cell, anaplastic large cell or immunoblastic NHL in recently attained complete response patients



  • 60 and over

Performance status:

  • Karnofsky at least 80%

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL unless there is a history of Gilbert's disease


  • No history of chronic renal insufficiency
  • Creatinine no greater than 1.5 mg/dL or if greater than 1.5 mg/dL, then creatinine clearance must be at least 60 mL/min


  • No myocardial infarction within the past 6 months
  • No unstable angina or cardiac arrhythmias other than chronic atrial fibrillation
  • Normal cardiac function required; MUGA scan or stress ECG ejection fraction at least 50% without significant wall motion abnormalities


  • Adequate pulmonary function defined as DLCO at least 50% of predicted value when corrected for patients hemoglobin and alveolar ventilation


  • No medical illness unrelated to intermediate grade Non-Hodgkin's Lymphoma
  • No uncontrolled infection
  • No history of malignancy other than curatively treated cutaneous basal cell carcinoma; carcinoma in situ of the cervix; axillary node negative breast cancer without prior chemotherapy and disease free for more than 2 years; or prostate cancer with surgery alone and disease free for more than 2 years
  • No lymphoblastic lymphoma, small noncleaved cell lymphoma, CNS lymphoma or CNS relapse of lymphoma
  • Not HIV, HBV, and HCV positive


  • Concurrent enrollment in MSKCC protocol 96-17a allowed

Biologic therapy:

  • Not specified


  • No more than 2 prior chemotherapy regimens

Endocrine therapy:

  • Not specified


  • Not specified


  • 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 identifier: NCT00002982

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Craig Moskowitz, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00002982     History of Changes
Other Study ID Numbers: 97-004
CDR0000065505 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: July 1, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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
anaplastic large cell 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
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists processed this record on April 24, 2017