Completed

Treatment for Extrachoroidal or Metastatic Retinoblastoma

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What is being tested

filgrastim

+ carboplatin

+ cyclophosphamide

BiologicalDrugProcedureRadiation
Who is being recruted

Eye Diseases+11

+ Eye Neoplasms

+ Neoplasms

Until 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1997
See protocol details

Summary

Principal SponsorSt. Jude Children's Research Hospital
Last updated: October 4, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Evaluate the feasibility of sequential therapy with carboplatin, etoposide, cyclophosphamide, doxorubicin, topotecan and radiotherapy followed by autologous bone marrow transplantation in patients with extrachoroidal or metastatic retinoblastoma. Assess this treatment regimen in terms of response and toxicity before and after autologous bone marrow transplantation in this patient population. OUTLINE: Patients receive carboplatin IV on day 1 and etoposide IV over 1 hour daily on days 1-3 of weeks 0, 6, and 12, plus cyclophosphamide IV or orally daily on days 1-7, doxorubicin IV on day 8 and carboplatin IV over 1 hour on day 10 on weeks 3, 9, and 15. Beginning on week 6, patients receive concurrent radiotherapy 5 days a week over 4-6 weeks. Patients with meningeal involvement receive topotecan intrathecally twice weekly for 3 weeks and then weekly for 3 weeks before starting radiotherapy. Beginning one day after each treatment course, patients receive filgrastim (G-CSF) subcutaneously daily for 10 days. Patients undergo bone marrow collection before or after week 6. Following hematologic recovery, patients receive several days of high dose chemotherapy consisting of cyclophosphamide and topotecan followed by bone marrow reinfusion. Patients are followed at 6, 9, and 12 months, and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

NCT00004006
Principal SponsorSt. Jude Children's Research Hospital
Last updated: October 4, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesEye NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal DiseasesEye Diseases, HereditaryNeuroectodermal TumorsNeoplasms, NeuroepithelialRetinal NeoplasmsRetinoblastoma

Criteria

DISEASE CHARACTERISTICS: Diagnosis of extrachoroidal or metastatic retinoblastoma, confirmed by histology, physical examination, or diagnostic imaging PATIENT CHARACTERISTICS: Age: 15 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy for low stage intraocular disease allowed Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except to eye(s) or orbit(s) Surgery: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Jude Children's Research Hospital

Memphis, United StatesOpen St. Jude Children's Research Hospital in Google Maps
CompletedOne Study Center