Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

Completed · Phase 3

Conditions studied: Extraocular Retinoblastoma

In brief

This phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.

Key facts

Study ID: NCT00554788
Run by: Children's Oncology Group
People needed: 60
Starts: 2008-05-06
Expected to finish: 2024-12-31
Last updated by the study team: 2025-01-13

Who can join

Age: any, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologic or cytologic verification of extra-ocular retinoblastoma; extra-ocular disease includes orbital disease, optic nerve involvement at the surgical margin, regional nodal disease, and/or overt distant metastatic disease (at sites such as bone, bone marrow, liver and/or the central nervous system); patients with trilateral retinoblastoma will also be included in this protocol
Patients with a CNS lesion consistent with trilateral or stage 4b disease may be enrolled without tissue confirmation if (1) unequivocal leptomeningeal disease is present on brain or spine magnetic resonance imaging (MRI) scan and/or (2) the primary tumor is at least 2 cm in diameter, predominantly solid, and demonstrates enhancement on the post-gadolinium images; however, even in such cases surgery should be given serious consideration
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
No prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma may have been administered prior to entering this study; prior treatment (chemotherapy and/or radiation therapy) for intra-ocular retinoblastoma is permissible
Peripheral absolute neutrophil count (ANC) >= 750/uL
If the ANC and/or platelet count are not adequate, but due to bone marrow metastatic disease, these criteria will be waived
Platelet count >= 75,000/uL (transfusion independent)
If the ANC and/or platelet count are not adequate, but due to bone marrow metastatic disease, these criteria will be waived
Creatinine clearance OR radioisotope glomerular filtration rate >= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
0.4 mg/dL (1 month to < 6 months of age)
0.5 mg/dL (6 months to < 1 year of age)
0.6 mg/dL (1 years to < 2 years of age)
0.8 mg/dL (2 years to < 6 years of age)
1.0 mg/dL (6 years to < 10 years of age)
1.2 mg/dL (10 years to < 13 years of age)
1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)
1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN)
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) for human studies must be met

Where it is running

University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
Phoenix Childrens Hospital — Phoenix, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center — Downey, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
UCSF Medical Center-Parnassus — San Francisco, California, United States
UCSF Medical Center-Mission Bay — San Francisco, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
Connecticut Children's Medical Center — Hartford, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
Nemours Children's Clinic - Orlando — Orlando, Florida, United States
Nemours Children's Hospital — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
University of Illinois — Chicago, Illinois, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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