A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma

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Brief Title

A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma

Official Title

A Pilot Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma

Brief Summary

      This study will test if giving topotecan directly into the blood vessel of the eye will
      improve the treatment of retinoblastoma. This method is referred to as "selective
      intra-ophthalmic artery chemotherapy" (SIOAC).

      The goals of this study are:

        -  To find out if topotecan is an effective treatment for retinoblastoma when delivered
           directly to the ophthalmic artery (SIOAC delivery)

        -  To find out what kind of effects (good and bad) can be expected when topotecan is given
           by SIOAC

        -  To assess visual pathway function before and after the study therapy

        -  To learn more about the pharmacology (how your body handles the drug) of topotecan when
           delivered directly to the ophthalmic artery
    


Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

1-year event-free survival (event defined as the need for external beam radiation or enucleation)

Secondary Outcome

 Visual pathway function

Condition

Retinoblastoma

Intervention

Intra-Ophthalmic Artery Topotecan Infusion

Study Arms / Comparison Groups

 Treatment of Retinoblastoma
Description:  Study of Intra-Ophthalmic Artery Topotecan infusion for the Treatment of Retinoblastoma.

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

36

Start Date

October 2011

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Age: 15 years of age or younger

          2. Diagnosis: Patients with untreated Group C/D/E unilateral Retinoblastoma at
             presentation without an indication for immediate enucleation (neovascular glaucoma or
             orbital pain) (Stratum A), or patients with a history of bilateral retinoblastoma and
             recurrent and/or refractory intraocular retinoblastoma where chemotherapy, external
             beam radiation and/or enucleation remain the only known option for disease control
             (Stratum B).

          3. Therapeutic Options: Chemotherapy, External Beam Radiation therapy and/or Enucleation

          4. Lansky ≥ 50 for patients ≤ 10 years of age; Karnofsky ≥ 50 for patients > 10 years of
             age. Patients who are unable to walk because of paralysis, but who are up in a
             wheelchair, will be considered ambulatory for the purpose of assessing the performance
             score.

          5. Prior Therapy: Stratum A: No prior therapy is allowed. Stratum B: 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. Prior radiation therapy is permitted.

          6. 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.

          7. Adequate Bone Marrow Function Defined as:

               -  Peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL

               -  Platelet count greater than or equal to 75,000/uL (transfusion independent,
                  defined as not receiving platelet transfusions within a 7-day period prior to
                  enrollment)

               -  Hemoglobin greater than or equal to 8.0 gm/dL (may receive RBC transfusions)

          8. Adequate Renal Function Defined as:

             -Maximum serum creatinine based on age as follows: 1 to < 2 years- 0.6 mg/dL; 2 to < 6
             years - 0.8 mg/dL; 6 to < 10 years- 1 mg/dL; 10 to < 13 years- 1.2 mg/dL; 13 to 15
             years- 1.5 mg/dL for boys and 1.4 mg/dL for girls.

             OR

             Creatinine clearance or radioisotope GFR greater than or equal to 70ml/min/1.73 m2

          9. Adequate Liver Function Defined As:

               -  Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 x upper
                  limit of normal (ULN) for age

               -  SGPT (ALT) less than or equal to 5 x upper limit of normal (ULN) for age

               -  Serum albumin greater than or equal to 2 g/dL

         10. Informed Consent: All patients and/or their parents or legal guardians must sign a
             written informed consent. Assent, when appropriate, will be obtained according to
             institutional guidelines.

         11. Patients of child-bearing potential must have a negative pregnancy test and agree to
             use an effective birth control method (abstinence is an acceptable form of birth
             control).

        Exclusion Criteria:

          1. Extra-ocular retinoblastoma or retinoblastoma involving the anterior chamber

          2. Retinoblastoma that could otherwise be treated with laser therapy, cryotherapy, or
             plaque therapy only

          3. Structural brain abnormality

          4. Uncontrolled infection, defined as requiring intravenous antibiotics at the time of
             enrollment

          5. Concomitant Medications

               -  Growth factors that support platelet or white cell number or function must not
                  have been administered within 3 days prior to enrollment.

               -  Patients who are currently receiving non-FDA approved drugs, or who have received
                  a non-FDA approved drug within 7 days prior to enrollment, are ineligible.

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

          6. 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 - 15 Years

Accepts Healthy Volunteers

No

Contacts

James Geller, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01466855

Organization ID

IARB1


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