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Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

Primary Purpose

Childhood Burkitt Lymphoma, Childhood Central Nervous System Germ Cell Tumor, Childhood Diffuse Large Cell Lymphoma

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

About this trial

This is an interventional treatment trial for Childhood Burkitt Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed refractory malignant solid tumor or lymphoma Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists Measurable or evaluable disease Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following: Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan Metastatic bone marrow disease Elevated tumor markers Presence of a malignant pleural effusion No leukemia Performance status - Karnofsky 50-100% (for patients > 10 years of age) Performance status - Lansky 50-100% (for patients ≤ 10 years of age) Not specified Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT ≤ 5 times ULN Albumin ≥ 2 g/dL Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min Creatinine based on age as follows: No greater than 0.8 mg/dL (for patients age 5 and under) No greater than 1.0 mg/dL (for patients age 6 to 10) No greater than 1.2 mg/dL (for patients age 11 to 15) No greater than 1.5 mg/dL (for patients age 16 and over) No arrhythmia on EKG No evidence of dyspnea at rest No exercise intolerance Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan Not pregnant Negative pregnancy test Fertile patients must use effective contraception Weight ≥ 10 kg Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only) No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed) No uncontrolled infection No history of life-threatening allergy to camptothecin derivatives or platinum agents No sensory or motor peripheral neuropathy ≥ grade 2 No elevation of amylase or lipase ≥ grade 2 Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide) Recovered from all prior immunotherapy At least 7 days since prior hematopoietic growth factors At least 7 days since prior antineoplastic biologic therapy Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease No concurrent immunotherapy No concurrent biologic therapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior oxaliplatin No other concurrent chemotherapy Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry See Biologic therapy Recovered from all prior radiotherapy At least 2 weeks since prior local palliative small port radiotherapy At least 6 months since prior TBI At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal radiotherapy At least 6 months since prior radiotherapy to ≥ 50 % of the pelvis At least 6 weeks since other prior substantial radiotherapy to the bone marrow No concurrent radiotherapy No other concurrent investigational drugs No other concurrent anticancer therapy No concurrent cephalosporin antibiotics No concurrent use of any of the following: Phenytoin Carbamazepine Oxcarbazepine Barbiturates Rifampin Phenobarbital Azole antifungal agents Aprepitant Hypericum perforatum (St. John's wort)

Sites / Locations

  • COG Phase I Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (irinotecan hydrochloride, oxaliplatin)

Arm Description

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT
Graded using the NCI CTCAE version 3.0.

Secondary Outcome Measures

Overall response assessed using RECIST criteria

Full Information

First Posted
January 7, 2005
Last Updated
June 4, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00101270
Brief Title
Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas
Official Title
A Phase I Study of Oxaliplatin (NSC# 266046, IND #57004) and Irinotecan in Pediatric Patients With Refractory Solid Tumors and Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2007 (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 when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in pediatric patients with refractory solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine, preliminarily, the antitumor activity of this regimen in these patients. II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin. Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (irinotecan hydrochloride, oxaliplatin)
Arm Type
Experimental
Arm Description
Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
Campto, Camptosar, CPT-11, irinotecan, U-101440E
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT
Description
Graded using the NCI CTCAE version 3.0.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Overall response assessed using RECIST criteria
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed refractory malignant solid tumor or lymphoma Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists Measurable or evaluable disease Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following: Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan Metastatic bone marrow disease Elevated tumor markers Presence of a malignant pleural effusion No leukemia Performance status - Karnofsky 50-100% (for patients > 10 years of age) Performance status - Lansky 50-100% (for patients ≤ 10 years of age) Not specified Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT ≤ 5 times ULN Albumin ≥ 2 g/dL Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min Creatinine based on age as follows: No greater than 0.8 mg/dL (for patients age 5 and under) No greater than 1.0 mg/dL (for patients age 6 to 10) No greater than 1.2 mg/dL (for patients age 11 to 15) No greater than 1.5 mg/dL (for patients age 16 and over) No arrhythmia on EKG No evidence of dyspnea at rest No exercise intolerance Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan Not pregnant Negative pregnancy test Fertile patients must use effective contraception Weight ≥ 10 kg Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only) No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed) No uncontrolled infection No history of life-threatening allergy to camptothecin derivatives or platinum agents No sensory or motor peripheral neuropathy ≥ grade 2 No elevation of amylase or lipase ≥ grade 2 Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide) Recovered from all prior immunotherapy At least 7 days since prior hematopoietic growth factors At least 7 days since prior antineoplastic biologic therapy Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease No concurrent immunotherapy No concurrent biologic therapy More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior oxaliplatin No other concurrent chemotherapy Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry See Biologic therapy Recovered from all prior radiotherapy At least 2 weeks since prior local palliative small port radiotherapy At least 6 months since prior TBI At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal radiotherapy At least 6 months since prior radiotherapy to ≥ 50 % of the pelvis At least 6 weeks since other prior substantial radiotherapy to the bone marrow No concurrent radiotherapy No other concurrent investigational drugs No other concurrent anticancer therapy No concurrent cephalosporin antibiotics No concurrent use of any of the following: Phenytoin Carbamazepine Oxcarbazepine Barbiturates Rifampin Phenobarbital Azole antifungal agents Aprepitant Hypericum perforatum (St. John's wort)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa McGregor
Organizational Affiliation
COG Phase I Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
COG Phase I Consortium
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

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