Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
NCT ID: NCT00007865
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2000-09-01
2008-04-22
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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rituximab
carboplatin
etoposide
ifosfamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
o CD20 positive
* Bidimensionally measurable or evaluable disease
* 19 years old and over
* ECOG 0-2 or Karnofsky 70-100%
* Life expectancy at least 3 months
* WBC at least 3,000/mm3
* Granulocyte count at least 1,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 times upper limit of normal(ULN)
* AST or ALT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 mg/dL
* Fertile patients must use effective contraception
* Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)
Exclusion Criteria
* Not pregnant or nursing/negative pregnancy test
* 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
* No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma
* No other concurrent chemotherapy
* No concurrent corticosteroids except transient administration as antiemetic
* No concurrent radiotherapy
* No other concurrent investigational therapy
* No other concurrent antitumor agents
19 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Julie M Vose, MD
Role: STUDY_CHAIR
University of Nebraska
Locations
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University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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NCI-V00-1635
Identifier Type: REGISTRY
Identifier Source: secondary_id
0032-00-FB
Identifier Type: -
Identifier Source: org_study_id