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Trial record 1 of 3 for:    "Retinoblastoma" | "cadexomer iodine"
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Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00079417
Recruitment Status : Completed
First Posted : March 10, 2004
Results First Posted : February 14, 2014
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intraocular Retinoblastoma
Interventions Procedure: cryosurgery
Procedure: infrared laser therapy
Radiation: iodine I 125
Radiation: ruthenium Ru 106
Drug: carboplatin
Drug: vincristine sulfate
Radiation: radiation therapy
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Period Title: Overall Study
Started 28
Completed 19
Not Completed 9
Reason Not Completed
Physician Decision             2
Ineligible             7
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
0.3
(0 to 2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
13
  46.4%
Male
15
  53.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   3.6%
Black or African American
4
  14.3%
White
19
  67.9%
More than one race
0
   0.0%
Unknown or Not Reported
4
  14.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
United States 27
Barbados 1
1.Primary Outcome
Title Event-free Survival
Hide Description Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients are reported. 7 patients were excluded due to ineligible status. Of the 7 patients, 1 was determined to have only a Group A involved eye and the other 6 had an intact eye that was Group C or D.
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description:

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.65
(0.40 to 0.82)
2.Secondary Outcome
Title Response Rate (RR) at Patient Level After the First Course of Therapy
Hide Description RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number of patients with Type I, II, III or IV response after first course of therapy
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients are reported. 7 patients were excluded due to ineligible status.
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description:

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.71
(0.48 to 0.89)
3.Secondary Outcome
Title Response Rate (RR) at Eye Levels After the First Course of Therapy
Hide Description RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number eyes with Type I, II, III or IV response after first course of therapy
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Group B eyes for the eligible patients. 4 patients were excluded due to ineligible status.
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description:

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of eyes
0.71
(0.49 to 0.87)
4.Secondary Outcome
Title Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level
Hide Description EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction
Time Frame 2 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
There were 15 eligible patients who responded to vincristine and carboplatin after an initial 1 cycle of therapy. 7 patients were excluded due to ineligible status.
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description:

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.60
(0.40 to 0.91)
5.Secondary Outcome
Title Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Participants with Grade 3 and higher reported on protocol therapy
Time Frame 6 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients are reported. 7 patients were excluded due to ineligible status.
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description:

Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.

cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.

infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects

iodine I 125: Undergo radioactive therapy

ruthenium Ru 106: Undergo radioactive therapy

carboplatin: Given IV

vincristine sulfate: Given IV

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Participants
Incidence of Catheter Related Infection 1
Incidence of Upper Respiratory Infection 1
Incidence of Dehydration 1
Incidence of Urticaria 1
Incidence of Neutrophils 6
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events grade 3 and above were considered as Serious Adverse Events in this study. All eligible patients are reported.
 
Arm/Group Title Vincristine Sulfate and Carboplatin and Surgery
Hide Arm/Group Description Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
All-Cause Mortality
Vincristine Sulfate and Carboplatin and Surgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vincristine Sulfate and Carboplatin and Surgery
Affected / at Risk (%)
Total   10/21 (47.62%) 
Infections and infestations   
Catheter related infection [1]  1/21 (4.76%) 
Upper respiratory infection [1]  1/21 (4.76%) 
Investigations   
Neutrophil count decreased [1]  6/21 (28.57%) 
Metabolism and nutrition disorders   
Dehydration [1]  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Urticaria [1]  1/21 (4.76%) 
[1]
Grades 3-5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vincristine Sulfate and Carboplatin and Surgery
Affected / at Risk (%)
Total   3/21 (14.29%) 
Investigations   
Neutrophil count decreased [1]  1/21 (4.76%) 
Platelet count decreased [1]  2/21 (9.52%) 
[1]
Grades 1-2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0567
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00079417     History of Changes
Other Study ID Numbers: ARET0331
NCI-2009-00422 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000355721 ( Other Identifier: Clinical Trials.gov )
COG-ARET0331 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 8, 2004
First Posted: March 10, 2004
Results First Submitted: December 23, 2013
Results First Posted: February 14, 2014
Last Update Posted: September 27, 2018