Filgrastim |
G-CSF; Neupogen |
Clinical Trial: Chemotherapy in Treating Patients With Retinoblastoma
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with retinoblastoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Retinoblastoma | Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: filgrastim Drug: mesna Drug: vincristine | Phase II |
MedlinePlus related topics: Eye Cancer
Genetics Home Reference related topics: retinoblastoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Adjuvant CBDCA for Intraocular Retinoblastoma Followed by CDDP/CTX/VCR/VP-16 for Residual Vitreous Disease
Study start: May 1995
OBJECTIVES: I. Estimate the response rate to adjuvant carboplatin (CBDCA) alone in children with intraocular retinoblastoma.
II. Assess the overall survival, disease-free survival, and time to treatment failure in these patients.
III. Attempt to maintain a 90% disease-free survival rate with this treatment.
IV. Estimate the percentage of disease-free survivors who do not require the use of radiotherapy after adjuvant CBDCA.
V. Assess the toxicity of this treatment.
VI. Estimate the percentage of functional eyes salvaged using this radiation-sparing protocol and compare these results, in a nonrandomized manner, with historical treatment results in this population.
PROTOCOL OUTLINE: Patients are stratified according to vitreous disease (yes vs no).
Patients receive carboplatin IV over 1 hour on day 0. Treatment repeats every 2-3 weeks for 2 courses. Patients achieving complete response (CR) proceed to local control measures consisting of cryotherapy, laser photocoagulation, etc. (except brachytherapy). Patients not achieving CR continue with carboplatin until local control measures feasible. Patients with vitreous disease achieving CR receive 2 additional courses and then receive local control measures. Patients with vitreous disease not achieving CR receive intensive chemotherapy.
Patients receive intensive chemotherapy consisting of vincristine IV on days 0, 7, and 14, cisplatin IV over 6 hours on day 0, etoposide IV on days 1 and 2, followed by cyclophosphamide IV over 60 minutes on days 1 and 2. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 3 and until blood counts recover. Treatment repeats every 2-4 weeks for 2 courses beyond CR.
Patients are followed for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-6 years.
Eligibility
Ages Eligible for Study: up to 17 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Intraocular retinoblastoma; Ophthalmologic exam under anesthesia within 3 weeks prior to registration; No pathologic confirmation required
- No evidence of extraocular disease, i.e.: Negative head MRI or CT (contrast not required); Negative CSF cytology; Negative bone marrow aspiration and biopsy
--Prior/Concurrent Therapy--
- No prior chemotherapy or radiotherapy
--Patient Characteristics--
- Age: Under 18
- Performance status: Not specified
- Hematopoietic: Not specified
- Hepatic: Bilirubin less than 2.0 mg/dl; SGOT or SGPT less than 5 times upper limit of normal
- Renal: Creatinine normal for age OR Creatinine clearance greater than 50 ml/min
Location Information
Ira Dunkel, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: July 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002675
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Filgrastim (Drug Digest)
- G-CSF (Drug Digest)

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