Topotecan Episcleral Plaque for Treatment of Retinoblastoma

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Brief Title

Topotecan Episcleral Plaque for Treatment of Retinoblastoma

Official Title

Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Brief Summary

      This single site, single-arm, non-randomized, dose escalation phase I toxicity clinical trial
      will assess primarily the safety and secondarily the efficacy of episcleral topotecan in
      patients with active residual or recurrent intraocular retinoblastoma in at least one eye
      following completion of first-line therapy.
    

Detailed Description

      Retinoblastoma is the most common pediatric malignant intraocular tumour and originates from
      the retina. Treatment of eyes with advanced intraocular retinoblastoma remains a challenge.
      The historic standard of care for patients with unilateral disease is enucleation and for
      those with bilateral disease, a variety of modalities have been tried. These include
      radiation therapy, systemic chemotherapy, periocular administration of chemotherapy,
      selective intra-arterial chemotherapy, and intravitreal chemotherapy. Unfortunately, all of
      these modalities are associated with significant morbidity and investigators are looking for
      new ways to treat these patients either with novel directed drug delivery methods or with new
      less toxic agents. This study will evaluate the safety and efficacy of topotecan delivered
      directly to the eye using a novel sustained-release topotecan episcleral plaque (also
      referred to as a Chemoplaque) in patients with active residual or recurrent intraocular
      retinoblastoma in at least one eye following completion of first-line therapy. The study
      intervention involves the insertion and removal of the Chemoplaque, examinations under
      anaesthesia (EUAs), visits to clinic to monitor for adverse events throughout, and post
      plaque removal toxicity evaluation. EUAs, clinic visits and laboratory tests are standard of
      care for retinoblastoma patients.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose and Recommended Phase 2 Dose of topotecan hydrochloride administered as a Chemoplaque to pediatric patients with active Retinoblastoma.

Secondary Outcome

 Tumor response to the Chemoplaque as secondary therapy in eye(s) with active retinoblastoma after completion of primary standard of care treatment.

Condition

Retinoblastoma

Intervention

Topotecan Episcleral Plaque

Study Arms / Comparison Groups

 Phase I single arm trial
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

30

Start Date

June 16, 2020

Completion Date

October 15, 2030

Primary Completion Date

October 15, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Age. Participants must be <18 years of age.

          2. Diagnosis and Treatment. Participants must have: (i) active residual or recurrent
             intraocular retinoblastoma following completion of first-line therapy (chemotherapy,
             systemic or intra-arterial, focal therapy or brachytherapy), or (ii) unilateral Group
             B, C, D or cT1b, cT2 retinoblastoma at diagnosis with no previous treatment.

          3. One eye will be the Study Eye. When participants have two eyes with retinoblastoma,
             the eye with worst disease or best vision potential will be designated the Study Eye.
             There will only be one eye per child treated in this Phase I study, since treatment of
             two eyes would double the systemic dose of drug. The Non-study eye will be treated by
             standard of care, with only focal therapy during the Study Period, if required.

          4. Disease status. Study eye must have vision potential and no clinical features
             suggestive of high risk of extraocular extension.

          5. Performance status. Lansky play score ≥ 50 if <16 years of age; Karnofsky performance
             scale of ≥ 50 if ≥16 years of age (Appendix I)

          6. Organ function:

               1. Adequate bone marrow function and platelet count

               2. Adequate renal function

               3. Adequate liver function

          7. Pregnancy prevention. Females of reproductive potential must agree to the use of
             highly effective contraception during study participation and for an additional 40
             days after the end of the Chemoplaque administration

          8. Informed consent. All participants and/or their parents or legally authorized
             representatives must have the ability to understand and the willingness to sign a
             written informed consent. Assent, where appropriate, will also be obtained.

        Exclusion Criteria:

          1. Disease status. Participants known to have any of the following are excluded:

               1. clinical or EUA evidence of extraocular extension

               2. known metastatic disease status and intercurrent illness

               3. existing clinical and neuroimaging showing suspicion of, or definitive,

          2. Allergy. Participants with reported allergy to topotecan, camptothecin or derivatives
             thereof.

          3. Concomitant treatment. Participants may not receive chemotherapy or other focal
             retinoblastoma therapy or any other investigational agent within 3 weeks of the
             placement and removal of the Chemoplaque, nor while the Chemoplaque is in situ.

          4. Uncontrolled intercurrent illness. Participants with known uncontrolled intercurrent
             illness that, in the investigator's opinion, would put the participant at undue risk
             or limit compliance with the study requirements.

          5. Febrile illness. Participants with clinically significant febrile illness (as
             determined by the investigator) within one week prior to initiation of protocol
             therapy.

          6. Pregnancy and lactation. Females of reproductive potential must have a negative serum
             pregnancy test within 72 hours prior to initiation of protocol therapy. Due to the
             unknown but potential risk for adverse events (AEs) in nursing infants secondary to
             treatment of the mother with the study agents, breastfeeding must be discontinued if
             the mother is treated on study.

          7. Compliance. Any condition of diagnosis that could in the opinion of the Principal
             Investigator or delegate interfere with the participant's ability to comply with the
             study instruction, might confound the interpretation of the study results, or put the
             participant at risk.
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Brenda Gallie, 416-813-7654, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04428879

Organization ID

1000064742


Responsible Party

Principal Investigator

Study Sponsor

The Hospital for Sick Children


Study Sponsor

Brenda Gallie, Principal Investigator, The Hospital for Sick Children


Verification Date

May 2021