Topotecan and Melphalan for Retinoblastoma

Study Purpose

The purpose of this study is to evaluate topotecan and melphalan for retinoblastoma patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - diagnosed as retinoblastoma.
  • - receiving eyeball-sparing treatment.

Exclusion Criteria:

- disease progression during follow-up

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04799002
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Huashen Yang
Principal Investigator Affiliation Sun Yat-sen University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Retinoblastoma, Chemotherapy Effect
Additional Details

To evaluate the effectiveness and complications of topotecan and melphalan for intraocular injection in retinoblastoma patients.

Arms & Interventions

Arms

Active Comparator: Topotecan

Topotecan intraocular injection during chemotherapy

Experimental: Melphalan

Melphalan intraocular injection during chemotherapy

Interventions

Drug: - Topotecan

Topotecan intraocular injection for chemotherapy in retinoblastoma

Drug: - Melphalan

Melphalan intraocular injection for chemotherapy in retinoblastoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen University, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University

Guangzhou, Guangdong, 510000

Site Contact

Huijing Ye, Doctor

[email protected]

00862087331539

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