Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00005631
First received: May 2, 2000
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy in treating patients who have relapsed or refractory large cell lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Biological: rituximab
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Cytoreduction and Stem Cell Mobilization With Rituximab and ICE for Patients With Refractory or Relapsed CD20+ B-Cell IGL Eligible for ASCT: The RICE Protocol

Resource links provided by NLM:


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

Study Start Date: November 1999
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the complete response rate in patients with relapsed or refractory CD20-positive diffuse large cell, immunoblastic, or anaplastic large cell lymphoma treated with cytoreduction and mobilization with rituximab, ifosfamide, carboplatin, and etoposide (RICE). II. Assess the ability of this regimen to deplete the stem cell harvest of B-cells and tumor cells in these patients. III. Assess the efficacy of this regimen to mobilize peripheral blood progenitor cells in these patients. IV. Assess the safety and toxicity of this regimen in these patients.

OUTLINE: Cytoreduction and mobilization: Patients receive ifosfamide IV over 24 hours and carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5. Chemotherapy repeats every 2 weeks for 3 courses. Patients receive rituximab IV on day -2 before initiation of chemotherapy and on day 1 of each course of chemotherapy. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily on days 7-14 of each course of chemotherapy. Patients with complete or partial response after completion of course 3 continue to receive G-CSF SC daily until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. If sufficient numbers of CD34+ cells are not obtained, patients undergo bone marrow harvest.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma that is in first relapse or refractory to primary therapy Eligible types: Diffuse large cell Immunoblastic Anaplastic large cell Eligible for autologous peripheral blood stem cell transplantation CD20-positive disease Measurable disease No brain parenchyma involvement

PATIENT CHARACTERISTICS: Age: 18 to 72 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL unless due to Gilbert's disease No chronic or persistent hepatitis Hepatitis B surface antigen negative Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min No chronic renal insufficiency Cardiovascular: Normal baseline cardiac function Ejection fraction at least 50% by echocardiogram or MUGA scan No myocardial infarction within the past 6 months No unstable angina No cardiac arrhythmias except chronic atrial fibrillation Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior rituximab allowed Chemotherapy: No prior carboplatin or cisplatin Endocrine therapy: Not specified Radiotherapy: Not specified 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: NCT00005631

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:
Publications:
ClinicalTrials.gov Identifier: NCT00005631     History of Changes
Other Study ID Numbers: 99-092, CDR0000067785, NCI-G00-1774
Study First Received: May 2, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Isophosphamide mustard
Rituximab
Ifosfamide
Carboplatin
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014