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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00075 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000405828 | |||
| OXALET | Other Identifier | St. Jude Children's Research Hospital | |
| 6634 | Other Identifier | CTEP | |
| P30CA021765 | U.S. NIH Grant/Contract | View source |
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This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients with recurrent or refractory solid tumors or lymphoma.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects of this regimen in these patients.
III. Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | 21 days | |
| MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0 | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa McGregor | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| etoposide | Drug | Given IV |
|
|
| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D064090 | Intraocular Lymphoma |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D012008 | Recurrence |
| D007943 | Leukemia, Hairy Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016399 | Lymphoma, T-Cell |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D015458 | Leukemia, T-Cell |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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