Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00007865
First received: January 6, 2001
Last updated: June 25, 2010
Last verified: June 2010
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Study Start Date: September 2000
Study Completion Date: April 2008
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in combination with rituximab.
  • Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients.

OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma

    • CD20 positive
  • Bidimensionally measurable or evaluable disease
  • No myelodysplastic syndrome or chronic myeloid leukemia

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm3
  • Granulocyte count at least 1,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
  • No active serious infection
  • No other concurrent serious medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids except transient administration as antiemetic
  • Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent investigational therapy
  • No other concurrent antitumor agents
  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: NCT00007865

Locations
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
Sponsors and Collaborators
University of Nebraska
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: Julie M. Vose, Pricipal Investigator, Unversity of Nebraka Medical Center
ClinicalTrials.gov Identifier: NCT00007865     History of Changes
Other Study ID Numbers: 032-00, P30CA036727, UNMC-032-00, NCI-V00-1635
Study First Received: January 6, 2001
Last Updated: June 25, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Nebraska:
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 adult Burkitt lymphoma
recurrent mantle 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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Etoposide phosphate
Isophosphamide mustard
Rituximab
Ifosfamide
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014