Adult Non-Hodgkin's Lymphoma |
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Clinical Trial: Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
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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 refractorynon-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult non-Hodgkin's lymphoma | Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: rituximab Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: monoclonal antibody therapy | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Ifosfamide, Carboplatin, Etoposide, and Rituximab in Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
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 above, Genders Eligible for Study: Both
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
Location Information
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States
Julie M. Vose, MD, Study Chair, University of Nebraska
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: January 6, 2001
ClinicalTrials.gov Identifier: NCT00007865
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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