Intra-arterial Chemotherapy for Retinoblastoma

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Brief Title

Intra-arterial Chemotherapy for Retinoblastoma

Official Title

Intra-arterial Chemotherapy for Retinoblastoma (IAC)

Brief Summary

      Children with retinoblastoma who may benefit from intra-arterial chemotherapy will receive up
      to 3 doses of melphalan and will be assessed for feasibility, toxicity, and response.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Feasibility of intra-arterial chemotherapy as measured by the number of participants who receive 3 intra-arterial injections of melphalan

Secondary Outcome

 Rate of procedure-related complications

Condition

Retinoblastoma

Intervention

Melphalan

Study Arms / Comparison Groups

 Intra-arterial injections of melphalan
Description:  -Participants will receive intra-arterial injections of melphalan Q4W for 3 cycles.

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

5

Start Date

August 11, 2020

Completion Date

May 31, 2024

Primary Completion Date

May 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients diagnosed with retinoblastoma >4 months of age16

          -  Patients whose other treatment options would require systemic chemotherapy,
             radiotherapy, or enucleation

          -  Patient or parent/legal guardian must sign a written informed consent

          -  One of a, b, or c:

               -  Patients who have bilateral COG stage B, C, D, or E retinoblastoma (refer to
                  Appendix A) who have undergone systemic chemotherapy without resolution (meaning
                  either has not had CR or has progressed despite systemic chemotherapy) and would
                  have the following treatment options remaining:

                    -  IAC

                    -  enucleation of one eye

                    -  local radiation

               -  Patients with non-germline retinoblastoma with unilateral disease who have COG A,
                  B, C, or D tumors (refer to Appendix A).

               -  Other patients may be considered on a case by case basis after discussion with
                  pediatric ophthalmology, hematology/oncology, and interventional neuroradiology.

        Exclusion Criteria:

          -  Opaque or hazy media which precluded visualization of the fundus.

          -  New or recurrent retinoblastoma that can be controlled with other conservative
             measures such as cryotherapy, thermotherapy, or plaque radiotherapy.

          -  Unilateral COG group E retinoblastoma (refer to Appendix A) with very poor visual
             prognosis as defined by pediatric ophthalmologist.

          -  Patients who would benefit from systemic chemotherapy.

          -  Patients with clinical or radiological evidence suggestive of retinoblastoma invasion
             of the optic nerve, choroid, sclera, orbit or metastatic sites.

          -  Currently receiving any other investigational agents.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to melphalan or other agents used in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia.

          -  Pregnant and/or breastfeeding. Participants of childbearing potential must have a
             negative pregnancy test within 14 days of study entry.

          -  Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
             they have a history of AIDS-defining opportunistic infection within the 12 months
             prior to registration. Concurrent treatment with effective ART according to DHHS
             treatment guidelines is recommended.
      

Gender

All

Ages

4 Months - N/A

Accepts Healthy Volunteers

No

Contacts

Margaret Reynolds, M.D., 314-454-6026, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04342572

Organization ID

202006160


Responsible Party

Sponsor

Study Sponsor

Washington University School of Medicine


Study Sponsor

Margaret Reynolds, M.D., Principal Investigator, Washington University School of Medicine


Verification Date

October 2021