Clinical trial · Interventional
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| B-cell Childhood Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Childhood Burkitt Lymphoma | Childhood Burkitt Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Childhood Grade III Lymphomatoid Granulomatosis | Childhood Grade III Lymphomatoid Granulomatosis | ONTOLOGY_EXACT | 0.98 |
| Childhood Immunoblastic Large Cell Lymphoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etoposide | Drug | Etoposide | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: oxaliplatin
- Drug: etoposide
Primary outcomes (2)
- measure
- MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- 21 days
- measure
- MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Life expectancy \> 8 weeks * Albumin \> 2 g/dL * Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed * Performance Status: Karnofsky \>= 50 % (patients \> 10 years of age) OR Lansky \>= 50% (patients for =\< 10 years of age) * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 (transfusion independent) * Hemoglobin \> 8 g/dL (transfusion allowed) * ALT \< 5.0 times ULN * Creatinine normal OR glomerular filtration rate \>= 80 mL/min/1.73 m\^2 * Calcium normal (electrolyte supplements allowed) * Echocardiogram and EKG normal * Shortening fraction \>= 27% OR ejection fraction \> 50% * No evidence of dyspnea at rest * No exercise intolerance * Pulse oximetry \> 94% on room air * Neurologic deficits due to CNS tumor must be relatively stable for \>= 2 weeks before study entry * Seizure disorder allowed provided well-controlled by non-enzyme-inducing anticonvulsants * No peripheral neurotoxicity \> grade 1 * Sodium, potassium, and magnesium normal (electrolyte supplements allowed) * At least 1 week since prior biologic agents * More than 1 week since prior growth factors * More than 6 months since prior allogeneic peripheral blood stem cell transplantation AND no active graft-versus-host disease * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites * More than 6 weeks since prior substantial bone marrow radiotherapy * More than 3 months since prior craniospinal (\> 24 Gy), whole pelvis, or total-body radiotherapy * Recovered from all prior therapy * No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the following: Barbiturates; Phenytoin; Carbamazepine Exclusion Criteria: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No history of life-threatening hypersensitivity to platinum-containing agents * No prior oxaliplatin * No other concurrent investigational agents * No other concurrent anticancer therapy * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
References
Publications (0)
Data not yet available