NCT00002794

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 1996

Longer than P75 for phase_2

Geographic Reach
1 country

2 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

February 1, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

April 26, 2004

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

October 3, 2011

Conditions

Retinoblastoma

Keywords

intraocular retinoblastoma

Interventions

carboplatinDRUG
vincristine sulfateDRUG

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam, ultrasound, CT, or MRI Fundus drawings and photographs required PATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (2)

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, 38103, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Related Links

MeSH Terms

Conditions

Retinoblastoma

Interventions

CarboplatinVincristine

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Carlos Rodriguez-Galindo, MD

    St. Jude Children's Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 26, 2004

Study Start

February 1, 1996

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

US(2)