RECRUITING

A Study to Give Treatment Inside the Eye to Treat Retinoblastoma

Talk to us

Conditions

Bilateral RetinoblastomaChildhood Intraocular RetinoblastomaGroup D RetinoblastomaStage I RetinoblastomaUnilateral Retinoblastoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests the safety and side effects of adding melphalan (by injecting it into the eye) to standard chemotherapy in early treatment of patients with retinoblastoma (RB). RB is a type of cancer that forms in the tissues of the retina (the light-sensitive layers of nerve tissue at the back of the eye). It may be hereditary or nonhereditary (sporadic). RB is considered harder to treat (higher risk) when there are vitreous seeds present. Vitreous seeds are RB tumors in the jelly-like fluid of the eye (called the vitreous humor). The term, risk, refers to the chance of the cancer not responding to treatment or coming back after treatment. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Other chemotherapy drugs given during this trial include carboplatin, vincristine, and etoposide. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Adding melphalan to standard chemotherapy early in treatment may improve the ability to treat vitreous seeds and may be better than standard chemotherapy alone in treating retinoblastoma.

Official Title

Intravitreal Melphalan for Intraocular Retinoblastoma

Quick Facts

Study Start:2022-11-04
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05504291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be \< 18 years of age at enrollment
  2. * Patient must have newly diagnosed intraocular (localized) retinoblastoma and meet one of the following criteria:
  3. * Unilateral Group D retinoblastoma with vitreous seeding; OR
  4. * Bilateral retinoblastoma with worst eye Group D, with vitreous seeding present and the contralateral eye is Group A-C; OR
  5. * Bilateral Group D retinoblastoma with at least one eye with vitreous seeding; OR
  6. * Bilateral retinoblastoma with one Group D eye with vitreous seeding and one Group E eye where the Group E eye has been enucleated prior to any therapy. Note exclusion for high-risk features
  7. * Bilateral retinoblastoma with one Group D eye with vitreous seeding and one Group E eye where the Group E eye has not been enucleated prior to any therapy at the discretion of the treating physician. Note exclusion for patients with evidence of metastatic or extra orbital spread
  8. * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\<16 years of age
  9. * Peripheral absolute neutrophil count (ANC) \>= 750/uL (must be performed within 7 days prior to enrollment unless otherwise indicated)
  10. * Platelet count \>= 75,000/uL (transfusion independent) (must be performed within 7 days prior to enrollment)
  11. * A serum creatinine based on age/gender as follows (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment):
  12. * 1 month to \< 6 months = 0.4 (male and female)
  13. * 6 months to \< 1 year = 0.5 (male and female)
  14. * 1 to \< 2 years = 0.6 (male and female)
  15. * 2 to \< 6 years = 0.8 (male and female)
  16. * 6 to \< 10 years = 1.0 (male and female)
  17. * 10 to \< 13 years = 1.2 (male and female)
  18. * 13 to \< 16 years = 1.5 (male) and 1.4 (female)
  19. * \>= 16 years = 1.7 (male) and 1.4 (female) OR - a 24-hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 OR - a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
  20. * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility
  21. * For patients \< 1 month of age, serum creatinine levels must be \< 1.5 x the treating institution's creatinine upper limit of normal (ULN) for patients \< 1 month of age or the creatinine clearance or radioisotope GFR must be \>= 70 mL/min/1.73 m\^2
  22. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
  23. * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
  24. * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
  1. * Patients with evidence of metastatic or extra-orbital spread
  2. * Patients must not have an invasive infection at time of protocol entry
  3. * Patients must not have had any prior anti-cancer therapy other than cryotherapy and/or laser therapy (green or infrared) to the study eye(s) and non-study eye, including systemic chemotherapy, intra-arterial chemotherapy, radioactive plaque, brachytherapy, or radiation therapy.
  4. * Note: A study eye is defined as being Group D with vitreous seeding. Patients may have had enucleation of one eye as long as the remaining eye is Group D with vitreous seeds
  5. * Patients with bilateral disease who undergo enucleation of a Group E eye prior to initiation of therapy and show evidence of high-risk histopathology features in the enucleated eye. High-risk histopathology includes choroid involvement \>= 3 mm, post lamina optic nerve involvement, full thickness scleral invasion or optic nerve invasion to the cut end
  6. * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  7. * Lactating females who plan to breastfeed their infants
  8. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  9. * All patients and/or their parents or legal guardians must sign a written informed consent
  10. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Contacts and Locations

Principal Investigator

Rachana Shah
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
M D Anderson Cancer Center
Houston, Texas, 77030
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Rachana Shah, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-04
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-11-04
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bilateral Retinoblastoma
  • Childhood Intraocular Retinoblastoma
  • Group D Retinoblastoma
  • Stage I Retinoblastoma
  • Unilateral Retinoblastoma