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Treatment for Extrachoroidal or Metastatic Retinoblastoma


Phase 2
N/A
15 Years
Not Enrolling
Both
Retinoblastoma

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Trial Information

Treatment for Extrachoroidal or Metastatic Retinoblastoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067217

NCT ID:

NCT00004006

Start Date:

November 1997

Completion Date:

September 2005

Related Keywords:

  • Retinoblastoma
  • intraocular retinoblastoma
  • extraocular retinoblastoma
  • recurrent retinoblastoma
  • Retinoblastoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794