Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma

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Brief Title

Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma

Official Title

A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)

Brief Summary

      The investigators are testing subtenon carboplatin in combination with vincristine and
      topotecan given by vein in the hopes of finding a drug combination that may be effective
      against retinoblastoma that has come back (recurrent) or is resistant to other treatment
      (refractory).

      The goals of this study are:

        -  To decide if the drug combination is a useful treatment for recurrent or refractory
           retinoblastoma

        -  To test the safety of the drug combination and to see what kind of effects (good and
           bad) can be expected from the drug combination

        -  To measure visual changes before and after the study therapy

        -  To use a special MRI scan to measure brain function involved in vision processing, both
           before and after the study therapy

      In this study, the investigators are also testing a new experimental way of giving
      carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through
      a needle placed under the covering of the eye. This is to try to get more carboplatin to the
      retinoblastoma inside the eye.
    



Study Type

Interventional


Primary Outcome

To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.

Secondary Outcome

 To describe the toxicities associated with the proposed regimen.

Condition

Retinoblastoma

Intervention

subtenon Carboplatin

Study Arms / Comparison Groups

 Topotecan/Vincristine with subtenon Carboplatin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

May 2010

Completion Date

March 2012

Primary Completion Date

March 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Age: ≤ 10 years of age

          -  Diagnosis: Patients must have a history of bilateral Retinoblastoma AND
             Recurrent/Refractory Intra-Ocular Retinoblastoma considered not amenable to cure with
             local therapies alone (photocoagulation with argon laser, cryotherapy, transpupillary
             thermotherapy, radioactive plaque therapy).

          -  Therapeutic Options: Patient's disease status is one for which there are no known
             options proven to provide a high chance for ocular salvage or cure other than external
             beam radiation or enucleation.

          -  Remaining visual function in target eye (s) is required

          -  Life Expectancy of > 8 weeks

          -  Lansky ≥ 50

          -  Prior Therapy: Patients must have local relapsed/refractory disease after receiving
             standard upfront therapy involving at least one chemotherapeutic regimen. There is no
             limit to prior chemotherapeutic regimens permitted. Patients may have received
             previous intravenous carboplatin, but may not have received prior subtenon carboplatin
             or intravenous topotecan.

          -  Patients must have recovered from the acute toxic effects of all prior chemotherapy,
             immunotherapy, or radiotherapy prior to entering this study, as described below:

               -  Myelosuppressive chemotherapy: patients must not have received myelosuppressive
                  chemotherapy within 3 weeks of study enrollment

               -  Biologic therapies: Patients must not have received biologic anti-cancer agents
                  within one week of study enrollment

          -  Radiation therapy: Four weeks must have elapsed since external beam radiation therapy,
             if given.

          -  Adequate Bone Marrow Function Defined as:

               -  Peripheral absolute neutrophil count (ANC) ≥ 750/µL

               -  Platelet count ≥ 75,000/µL (transfusion independent, defined as not receiving
                  platelet transfusions within a 7-day period prior to enrollment)

               -  Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions)

          -  Adequate Renal Function Defined as:

               -  Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR threshold
                  creatinine values based on age/gender derived from the Schwartz formula for
                  estimating GFR

          -  Adequate Liver Function Defined As:

               -  Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN)
                  for age

               -  SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age

               -  Serum albumin ≥ 2 g/dL

        Exclusion Criteria:

          -  Extra-ocular retinoblastoma

          -  Asynchronous involvement of the contralateral eye, previously untreated

          -  Uncontrolled infection at time of protocol entry

          -  Concomitant Medications:

               -  Growth factors that support platelet or white cell number or function must not
                  have been administered within the past 3 days

               -  Patients who are currently receiving investigational drugs, or who have received
                  an investigational drug within the last 7 days, are ineligible

               -  Patients who are currently receiving other anti-cancer agents are ineligible

          -  Patients who in the opinion of the investigator may not be able to comply with the
             safety monitoring requirements of the study are not eligible
      

Gender

All

Ages

N/A - 10 Years

Accepts Healthy Volunteers

No

Contacts

James Geller, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00980551

Organization ID

RELRB1


Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

James Geller, MD, Principal Investigator, Children's Hospital Medical Center, Cincinnati


Verification Date

February 2017