NCT00024284

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2001

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

2.5 years

First QC Date

September 13, 2001

Last Update Submit

April 3, 2013

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Interventions

carboplatinDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor, including primary brain tumor * Progressive disease on standard therapy or for which no standard therapy exists * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 1 to 21 Performance status: * Lansky 50-100% (age 10 and under) * Karnofsky 50-100% (over age 10) Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT no greater than 2.5 times upper limit of normal Renal: * Glomerular filtration rate at least 30 mL/min Other: * No active infection * No serious uncontrolled medical disorder * No psychiatric disorder or other disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease * At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * No more than 3 prior chemotherapy regimens * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * Concurrent hormone replacement therapy or oral contraceptives allowed * No other concurrent hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational anticancer drugs * No other concurrent antitumor therapy * No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2916, United States

Location

Washington University Medical Center

St Louis, Missouri, 63105, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

CarboplatinIrinotecan

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Ashwin Gollerkeri, MD

    Bristol-Myers Squibb

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

CA(1)US(6)