Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia
Stopped early · Phase 2
Conditions studied: B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, L3 Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma
In brief
This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and etoposide works in treating young patients with recurrent or refractory non-Hodgkin's lymphoma or acute lymphoblastic leukemia. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in 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. Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.
Key facts
- Study ID
- NCT00058461
- Run by
- National Cancer Institute (NCI)
- People needed
- 82
- Starts
- 2003-11-01
- Last updated by the study team
- 2013-10-08
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia
- CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining)
- The following histologies are generally CD20+ and are eligible:
- Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma, or follicular lymphoma, grade III (rare), documented by flow cytometry or appropriate immunohistochemistry, any stage
- Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage
- B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or demonstration of surface immunoglobin by flow cytometry
- Atypical precursor B-cell lymphoblastic lymphoma or other unusual histologies that are CD20+
- Measurable disease by clinical, radiographic, or histologic criteria
- Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
- No isolated CNS disease
- Performance status - ECOG 0-2
- At least 2 months
- Absolute neutrophil count ≥ 1,000/mm\^3*
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)*
- Hemoglobin ≥ 10.0 g/dL (RBC transfusion allowed)*
- Bilirubin ≤ 1.5 times normal
- ALT < 2.5 times normal
- No chronic renal insufficiency
- Renal insufficiency allowed provided it is secondary to tumor lysis syndrome
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study treatment
- HIV negative
- No active uncontrolled infection
- Seizure disorder allowed if well controlled with anticonvulsants
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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