Trial Comparing Two Carboplatin Doses in Groups C and D Intraocular Retinoblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Council of Scientific and Industrial Research, India
Information provided by (Responsible Party):
Rachna Meel, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00889018
First received: April 27, 2009
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine whether an increase in the dose of carboplatin in treatment of advanced intraocular (group C and D) retinoblastoma helps in avoiding radiotherapy and improves the rate of globe salvage.


Condition Intervention
Intraocular Retinoblastoma
Drug: carboplatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Comparing Carboplatin 560mg/m2 With 750mg/m2 for Ocular Salvage in Groups C and D Intraocular Retinoblastoma

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Ocular salvage rates in two randomly divided groups of group C and D retinoblastomas, treated with primary chemotherapy protocol using 560mg/m2 carboplatin and 750mg/m2 carboplatin respectively [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the response of subtenon carboplatin injections in cases of group C and D retinoblastomas that fail to respond to primary chemotherapy and local treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 1
chemotherapy using carboplatin 560mg/m2
Drug: carboplatin
Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 560 mg/m2 (18.6 mg/kg for children £36 months old). .
Other Name: paraplatin
Experimental: group 2
chemotherapy using 750mg/m2 carboplatin
Drug: carboplatin
Table. 1: Chemotherapy protocol Vincristine Etoposide Carboplatin Day1 + + + Day2 ---- + ---- This regimen is repeated once a month for 6 months.Dose:Vincristine: 1.5 mg/m2 (0.05 mg/kg for children £36 months old and maximum dose 2 mg).Etoposide: 150 mg/m2 (5 mg/kg for children £36 months old).Carboplatin: 750 mg/m2 (25 mg/kg for children £36 months old).
Other Name: paraplatin

Detailed Description:

Chemoreduction has become an important method in management of retinoblastoma. This technique has been employed in an effort to avoid enucleation and external beam radiotherapy (EBRT) for children with intraocular retinoblastoma, especially those with bilateral disease. Although an ideal regimen for chemoreduction has not been determined, most authors use a combination of vincristine, etoposide and carboplatin for 2- 6 cycles along with local treatment including cryotherapy, laser photocoagulation, thermotherapy and plaque radiotherapy. Chemoreduction along with local treatment has been shown to have high treatment success in groups A and B of retinoblastoma allowing globe salvage without need of EBRT. But globe salvage rates remain low in groups C and D, which mostly need enucleation, or EBRT in a large number of cases.

In bilateral retinoblastoma where one eye is already lost owing to enucleation or both the eyes have advanced retinoblastoma (group C/D) globe salvage assumes a significant role in the overall treatment. Recurrences of the vitreous seeds or the sub retinal seeds are the main causes of treatment failure with chemoreduction and local treatment, ultimately requiring enucleation or EBRT.

The recurrence of vitreous or subretinal seeds do not necessarily mean a tumor resistance, it may reflect an inadequate penetration of the chemotherapeutic agents in these relatively avascular sites i.e the vitreous cavity or the subretinal space.

The penetration to these sites could be enhanced by (a) increase in the dose of the intravenous chemotherapeutic agents. The IInd Toronto protocol that was started in 2000 explores this option. The initial reports are encouraging but they have used high doses chemotherapy in combination with cyclosporin A. Therefore the effect of high dose chemotherapy on the globe salvage rates in groups C and D cannot be evaluated as an independent factor. (b) Periocular carboplatin injection has proven to deliver much higher levels of the drug in to the vitreous cavity, but several studies have revealed local side effects of this apparently harmless technique.The National Collaborative Retinoblastoma Study funded by the Children's oncology group plans to carry out a single arm trial of 6 cycles of systemic high dose chemotherapy and subtenon carboplatin injections in groups C and D of retinoblastoma. (c) Use of Cryotherapy/thermotherapy along with chemotherapy, has shown to increase the penetration of the chemotherapeutic agents into the vitreous cavity probably by disrupting the blood retinal barrier.

Shield's et al has already shown that the 6 cycle chemotherapy regimen achieves better long-term control of vitreous and subretinal seeds as compared to a 2 cycle regimen.

We planned this study to compare two different dose schedules of carboplatin and compare the rate of globe salvage in group C and D retinoblastoma and also to evaluate the effect of subtenon Carboplatin injections in cases that fail to respond to primary chemotherapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All new cases of retinoblastoma with group C or D tumor as per the ICRB (International classification of retinoblastoma, Table 2) that present at Rajendra Prasad Centre for Ophthalmic Sciences over first 2 years of the study period

Exclusion Criteria:

  • Biomicroscopic evidence of iris neovascularization
  • Neovascular glaucoma
  • Tumor invasion into the anterior chamber, iris, optic nerve, choroid, or extraocular tissues as documented by clinical, ultrasonographic, and neuroimaging modalities.
  • Systemic exclusion criteria include:

    • evidence of systemic metastasis
    • prior chemotherapy
    • prior treatment for retinoblastoma, or
    • inadequate renal or hepatic function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889018

Locations
India
Dr RPC AIIMS
Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Council of Scientific and Industrial Research, India
Investigators
Principal Investigator: Rachna Meel, MS Ophthal Dr RPC, AIIMS
Study Chair: Supriyo Ghose, MS Ophthal Prof and HOD, Dr RPC, AIIMS
Study Chair: Sameer Bakhshi, MD Paeds Associate Prof., IRCH, AIIMS
Study Chair: Neelam Pushker, MD Ophthal Associate Prof., Dr RPC, AIIMS
  More Information

No publications provided

Responsible Party: Rachna Meel, Senior Research Associate, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00889018     History of Changes
Other Study ID Numbers: RACHNAMEEL
Study First Received: April 27, 2009
Last Updated: February 7, 2012
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
intraocular retinoblastoma
chemotherapy

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014