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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058461 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: carboplatin Drug: cytarabine Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: methotrexate Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Rituximab And ICE Chemotherapy In Children With Recurrent/Refractory B-Cell (CD20+) Non-Hodgkin Lymphoma And B-Cell Acute Lymphoblastic Leukemia |
Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified by disease (B-cell large cell lymphoma or atypical precursor B-cell lmphoblastic lymphoma vs small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia).
Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5, rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
Patients also receive intrathecal (IT) chemotherapy comprising methotrexate and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per disease stratum) will be accrued for this study within 2-4 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia
The following histologies are generally CD20+ and are eligible:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
No chronic renal insufficiency
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior stem cell transplantation allowed provided the following criteria are met:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Timothy C. Griffin, MD | Cook Children's Medical Center - Fort Worth |
Study ID Numbers: | CDR0000298751, COG-ANHL0121 |
Study First Received: | April 7, 2003 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00058461 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood large cell lymphoma B-cell childhood acute lymphoblastic leukemia childhood diffuse large cell lymphoma recurrent childhood small noncleaved cell lymphoma |
childhood immunoblastic large cell lymphoma L3 childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma Burkitt lymphoma |
Leukemia, Lymphoid Lymphoma, small cleaved-cell, diffuse Etoposide phosphate Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Lymphoma, B-Cell Lymphoma, large-cell Leukemia Burkitt's lymphoma Lymphoma, Large-Cell, Immunoblastic Methotrexate Epstein-Barr Virus Infections Etoposide Lymphoma Cytarabine |
Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Rituximab Carboplatin Lymphoblastic lymphoma Recurrence Herpesviridae Infections Folic Acid Virus Diseases Lymphatic Diseases Ifosfamide Burkitt Lymphoma B-cell lymphomas DNA Virus Infections |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections Reproductive Control Agents Neoplasms, Experimental Therapeutic Uses Abortifacient Agents Alkylating Agents |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Antineoplastic Agents, Alkylating Antirheumatic Agents |