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Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Primary Purpose

Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
etoposide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm 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.

Outcomes

Primary Outcome Measures

MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0

Secondary Outcome Measures

Full Information

First Posted
January 7, 2005
Last Updated
February 21, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00101205
Brief Title
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Noncutaneous Extranodal Lymphoma, Peripheral T-cell Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Small Intestine Lymphoma, T-cell Childhood Acute Lymphoblastic Leukemia, T-cell Large Granular Lymphocyte Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
EPEG, VP-16, VP-16-213
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame
21 days
Title
MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0
Time Frame
21 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa McGregor
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

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Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma

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