Irinotecan in Treating Children With Refractory Solid Tumors

NCT ID: NCT00004078

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (irinotecan hydrochloride)

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.

Group Type: EXPERIMENTAL

irinotecan hydrochloride

Intervention Type: DRUG

Given IV

Interventions

irinotecan hydrochloride

Given IV

Intervention Type: DRUG

Other Intervention Names

Campto; Camptosar; CPT-11; irinotecan; U-101440E

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Bomgaars

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Oncology Group

Arcadia, California, United States

Countries

United States

Other Identifiers

NCI-2012-02310

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000067288

Identifier Type: OTHER

Identifier Source: secondary_id

POG-9761

Identifier Type: OTHER

Identifier Source: secondary_id

CCG-P9761

Identifier Type: OTHER

Identifier Source: secondary_id

COG-P9761

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P9761

Identifier Type: -

Identifier Source: org_study_id