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Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma Clinical research trials and Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma. Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma  Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma
Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma
For Condition: intraocular retinoblastoma
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy, with or without low-dose radiation therapy, is effective in treating intraocular (within the eyeball) retinoblastoma. PURPOSE: Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy with or without low-dose radiation therapy in treating children who have intraocular retinoblastoma.
Details: OBJECTIVES: Primary - Determine the event-free survival of pediatric patients with group C or D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine, carboplatin, and etoposide, subtenon carboplatin, and local ophthalmic therapy and with addition of low-dose radiotherapy in patients with group D intraocular retinoblastoma. Secondary - Determine the acute and long-term toxic effects of these regimens in these patients, including visual outcome and incidence of secondary malignancies. - Determine the patterns of failure in patients treated with these regimens, in terms of vitreous vs retinal vs both as sites of recurrence. OUTLINE: This is a multicenter study. Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 4 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or cryotherapy on day 1. Beginning 4 weeks after the last course of systemic chemotherapy, patients with group D intraocular retinoblastoma undergo radiotherapy 5 days a week for 2.5 weeks (13 treatments). Patients are followed every 3 weeks until there is no active tumor seen on a minimum of 3 exams under anesthesia, every 6-8 weeks until 3 years of age, every 3 months until 5 years of age, every 4-6 months until 10 years of age, and then annually thereafter. PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following: - Localized vitreous and/or subretinal seeding* (less than 6 mm in total from tumor margin) - No tumor masses, clumps, or snowballs in vitreous or subretinal space NOTE: *If more than 1 site of subretinal/vitreous seeding is present, total of sites must be less than 6 mm from tumor margin - Diffuse vitreous and/or subretinal seeding** (at least 6 mm in total from tumor margin) and/or subretinal fluid more than 6 mm from tumor margin NOTE: **If more than 1 site of subretinal/vitreous seeding is present, total of sites must be at least 6 mm from tumor margin - Prior enucleation of 1 eye allowed provided the remaining eye is group C or D - No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry - Evidence of choroidal and/or optic nerve invasion past the lumina cribosa is allowed - No extraocular retinoblastoma clinically or by MRI of brain and orbits with and without gadolinium or CT scan with and without contrast of brain and orbits PATIENT CHARACTERISTICS: Age - Under 18 Performance status - ECOG 0-2 - Karnofsky 50-100% (over 16 years of age) - Lansky 50-100% (16 and under) Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT less than 2.5 times ULN Renal - Creatinine normal for age as follows: - No greater than 0.8 mg/dL (5 years of age and under) - No greater than 1.0 mg/dL (6-10 years of age) - No greater than 1.2 mg/dL (11-15 years of age) - No greater than 1.5 mg/dL (over 15 years of age) Other - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No other concurrent radiotherapy Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyMurray, , Sylvester Cancer Center
Additional Information:
Study ID Numbers: CDR0000339627; COG-ARET0231
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072384
Other Intraocular Retinoblastoma Studies:
1. Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
2. Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma
3. Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
4. Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma
Related Studies:
Other intraocular retinoblastoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma
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