Trials / Completed
CompletedNCT00007865
Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Nebraska · Academic / Other
- Sex
- All
- Age
- 19 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rituximab | |
| DRUG | carboplatin | |
| DRUG | etoposide | |
| DRUG | ifosfamide |
Timeline
- Start date
- 2000-09-01
- Primary completion
- 2004-03-01
- Completion
- 2008-04-22
- First posted
- 2003-01-27
- Last updated
- 2023-12-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00007865. Inclusion in this directory is not an endorsement.