Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 19 - 120 |
Updated: | 1/19/2018 |
Start Date: | September 2000 |
End Date: | April 2008 |
A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
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.
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.
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.
- 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.
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
We found this trial at
1
site
985950 Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
402-559-4090
UNMC Eppley Cancer Center at the University of Nebraska Medical Center The Fred & Pamela...
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