Chemotherapy Treatment for Children With Intraocular Germ-Line Retinoblastoma
Raktažodžiai
Santrauka
Datos
Paskutinį kartą patikrinta: | 07/31/2020 |
Pirmasis pateikimas: | 09/11/2005 |
Numatytas registravimas pateiktas: | 09/11/2005 |
Pirmas paskelbtas: | 09/15/2005 |
Paskutinis atnaujinimas pateiktas: | 08/02/2020 |
Paskutinis atnaujinimas paskelbtas: | 08/04/2020 |
Faktinė studijų pradžios data: | 03/31/1996 |
Numatoma studijų užbaigimo data: | 08/31/2006 |
Būklė ar liga
Intervencija / gydymas
Drug: Carboplatin
Drug: VP-16
Procedure: Local Surgery
Procedure: Cryotherapy
Procedure: Laser hyperthermia
Fazė
Tinkamumo kriterijai
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Eligibility Criteria: - Initial clinical diagnosis of Retinoblastoma, with Bilateral tumors, OR Unilateral tumor with hope for salvage of vision AND Multiple primary tumors, or positive family history for retinoblastoma, or age < 12 months - No prior antitumor therapy (except enucleation of one eye) - At least one tumor exceeds 6 mm in diameter - No evidence of dissemination outside the globe - Signed IRB-approved informed consent - Patient/family available for follow-up |
Rezultatas
Pirminės rezultatų priemonės
1. To determine if a multimodal approach can provide durable control of retinoblastoma and specifically: [undefined]
2. Estimate the proportion of eyes in which radiation therapy can be omitted [undefined]
3. Estimate the proportion of eyes in which vision can be retained [undefined]
Antrinės rezultatų priemonės
1. To estimate the response rate and duration for primary retinoblastoma tumors to combination therapy with carboplatin and VP-16 [undefined]
2. To estimate the response rate of qualifying in situ retinoblastoma tumors to local surgical therapies, specifically estimate tumor response and duration after laser hyperthermia concurrent with carboplatin [undefined]
3. Estimate tumor response and duration after cryotherapy [undefined]
4. To estimate the control rate of vitreous involvement by retinoblastoma to carboplatin and VP-16 [undefined]
5. To detect any toxicities resulting from multimodal therapy plus local surgical options [undefined]