Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101205
First received: January 7, 2005
Last updated: May 1, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Burkitt Lymphoma Childhood Central Nervous System Germ Cell Tumor Childhood Diffuse Large Cell Lymphoma Childhood Grade III Lymphomatoid Granulomatosis Childhood Immunoblastic Large Cell Lymphoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Ependymoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Liver Cancer Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Medulloblastoma Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor Recurrent Childhood Visual Pathway Glioma Recurrent Colon Cancer Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Melanoma Recurrent Nasopharyngeal Cancer Recurrent Neuroblastoma Recurrent Osteosarcoma Recurrent Wilms Tumor and Other Childhood Kidney Tumors Recurrent/Refractory Childhood Hodgkin Lymphoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: oxaliplatin Drug: etoposide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Hodgkin Disease
Kidney Cancer
Liver Cancer
Lymphoma
Melanoma
Neuroblastoma
Soft Tissue Sarcoma
Wilms' Tumor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | November 2004 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: oxaliplatin
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101205
Locations
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Lisa McGregor | St. Jude Children's Research Hospital |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00101205 History of Changes |
| Other Study ID Numbers: | NCI-2009-00075, OXALET, CDR0000405828 |
| Study First Received: | January 7, 2005 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Astrocytoma Burkitt Lymphoma Colonic Neoplasms Ependymoma Glioma Hodgkin Disease Kidney Neoplasms Liver Neoplasms Lymphoma Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Medulloblastoma Melanoma Wilms Tumor Neuroblastoma |
Osteosarcoma Rhabdomyosarcoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Nasopharyngeal Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Rhabdomyosarcoma, Embryonal Sarcoma Optic Nerve Glioma Lymphoma, Extranodal NK-T-Cell Neoplasms Sarcoma, Ewing's |
ClinicalTrials.gov processed this record on May 22, 2013