NCT00554788|CompletedPhase 3ResultsDMC

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

Children's Oncology Group ClinicalTrials.gov

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6 other identifiers

ARET0321NCI-2009-00421CDR0000573987COG-ARET0321U10CA180886U10CA098543

Study Type

interventional

Target

Locations

6 countries

Sites

Timeline

RegisteredNov 2007

StartedMay 2008

CompletionDec 2024

Brief Summary

This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started May 2008

Longer than P75 for phase_3

Geographic Reach

6 countries

73 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

16.7 years study duration

First Submitted

Initial submission to the registry

November 6, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed

6 months until next milestone

Study Start

First participant enrolled

May 6, 2008

Completed

10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed

12 months until next milestone

Results Posted

Study results publicly available

June 26, 2019

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

10.2 years

First QC Date

November 6, 2007

Results QC Date

June 5, 2019

Last Update Submit

January 3, 2025

Conditions

Extraocular Retinoblastoma

Outcome Measures

Primary Outcomes (1)

Event-free Survival (EFS)
The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.
At 1 year

Secondary Outcomes (2)

Response Rate to the Induction Phase of the Regimen
12 weeks after participant received the first dose
Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (chemotherapy, radiotherapy, autologous SCI)

EXPERIMENTAL

INDUCTION: Patients receive vincristine IV; cisplatin IV; cyclophosphamide IV; and G-CSF SC beginning on day 3 and continuing until blood counts recover. CONSOLIDATION (stage 4a or 4b disease only): Patients receive carboplatin IV; thiotepa IV; and etoposide IV. AUTOLOGOUS STEM CELL INFUSION (stage 4a or 4b disease only): Patients undergo autologous stem cell infusion on day 0 and receive G-CSF SC beginning on day 1 and continuing until blood counts recover. RADIOTHERAPY: Patients with stage 2 or 3 disease (orbital and/or regional involvement) undergo radiotherapy to sites that were initially involved beginning within 42 days after the start of course 4 of induction chemotherapy. Patients with stage 4a or 4b disease undergo radiotherapy to sites initially involved based on response beginning approximately 42 days after autologous stem cell infusion.

Procedure: Autologous Bone Marrow TransplantationProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: CarboplatinDrug: CisplatinDrug: CyclophosphamideDrug: EtoposideBiological: FilgrastimProcedure: In Vitro-Treated Peripheral Blood Stem Cell TransplantationRadiation: Radiation TherapyDrug: ThiotepaDrug: Vincristine Sulfate

Interventions

Autologous Bone Marrow TransplantationPROCEDURE

Undergo peripheral blood stem cell or bone marrow transplant

Also known as: ABMT, Autologous Blood and Marrow Transplantation, Autologous Bone Marrow Transplant, Autologous Marrow Transplantation