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Irinotecan in Treating Children With Refractory Solid Tumors

Primary Purpose

Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Central Nervous System Germ Cell Tumor

Eligibility Criteria

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

Inclusion Criteria: Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy Solid tumors: Neuroblastoma Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET) Osteosarcoma Rhabdomyosarcoma Other extracranial solid tumors CNS tumors: Medulloblastoma/PNET Ependymoma Brain stem glioma Other CNS tumor Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery) Classic optic glioma (histologic requirement waived) Measurable disease by imaging studies No lesions assessable only by radionuclide scan Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size Performance status - Karnofsky 50-100% if more than 10 years old Performance status - Lansky 50-100% if 10 years or younger At least 8 weeks Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8 mg/dL Inadequate peripheral blood counts due to bone marrow infiltration allowed Bilirubin no greater than 1.5 mg/dL SGPT less than 5 times normal Creatinine normal Glomerular filtration rate at least 70 mL/min No severe uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study At least 3 weeks since prior immunotherapy and recovered No concurrent biologic therapy At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered No more than 2 prior chemotherapy regimens No other concurrent chemotherapy Prior topotecan allowed No prior irinotecan Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study At least 3 weeks since prior endocrine therapy No other concurrent endocrine therapy See Disease Characteristics At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered No prior total body radiotherapy No concurrent radiotherapy See Disease Characteristics At least 3 weeks since prior investigational agents No other concurrent investigational agents No concurrent anticonvulsants No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)

Sites / Locations

  • Children's Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (irinotecan hydrochloride)

Arm Description

Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.

Outcomes

Primary Outcome Measures

Objective response (PR or CR), recorded according to standard solid tumor response criteria

Secondary Outcome Measures

Toxicity, graded using the NCI CTCAE version 2.0
Pharmacokinetics of irinotecan hydrochloride

Full Information

First Posted
December 10, 1999
Last Updated
June 13, 2013
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004078
Brief Title
Irinotecan in Treating Children With Refractory Solid Tumors
Official Title
Phase II Trial of Irinotecan in Children With Refractory Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed Description
OBJECTIVES: I. Determine the efficacy of irinotecan in children with refractory CNS or solid tumors. II. Assess the toxicity, pharmacokinetics, and pharmacodynamics of this regimen in this patient population. III. Determine patient UGT1A1 genotype and correlate genotype with toxicity and pharmacokinetic parameters of this regimen in these patients. OUTLINE: Patients are stratified according to type of solid tumor (Ewings/PNET vs neuroblastoma vs osteosarcoma vs rhabdomyosarcoma vs other solid tumors excluding lymphomas and brain tumors) or brain tumor (medulloblastoma/PNET vs brain stem glioma vs ependymoma vs other CNS tumors). Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood Infratentorial Ependymoma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (irinotecan hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive irinotecan IV over 60 minutes on days 1-5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 4 years and then annually thereafter until death or until patient enters another POG study.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
Campto, Camptosar, CPT-11, irinotecan, U-101440E
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective response (PR or CR), recorded according to standard solid tumor response criteria
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
Toxicity, graded using the NCI CTCAE version 2.0
Time Frame
Up to 8 years
Title
Pharmacokinetics of irinotecan hydrochloride
Time Frame
Day 1 of course 1

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 or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy Solid tumors: Neuroblastoma Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET) Osteosarcoma Rhabdomyosarcoma Other extracranial solid tumors CNS tumors: Medulloblastoma/PNET Ependymoma Brain stem glioma Other CNS tumor Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery) Classic optic glioma (histologic requirement waived) Measurable disease by imaging studies No lesions assessable only by radionuclide scan Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size Performance status - Karnofsky 50-100% if more than 10 years old Performance status - Lansky 50-100% if 10 years or younger At least 8 weeks Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8 mg/dL Inadequate peripheral blood counts due to bone marrow infiltration allowed Bilirubin no greater than 1.5 mg/dL SGPT less than 5 times normal Creatinine normal Glomerular filtration rate at least 70 mL/min No severe uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study At least 3 weeks since prior immunotherapy and recovered No concurrent biologic therapy At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered No more than 2 prior chemotherapy regimens No other concurrent chemotherapy Prior topotecan allowed No prior irinotecan Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study At least 3 weeks since prior endocrine therapy No other concurrent endocrine therapy See Disease Characteristics At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered No prior total body radiotherapy No concurrent radiotherapy See Disease Characteristics At least 3 weeks since prior investigational agents No other concurrent investigational agents No concurrent anticonvulsants No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Bomgaars
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Oncology Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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Irinotecan in Treating Children With Refractory Solid Tumors

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