Pilot Study of Topotecan/Vincristine With Subconjunctival Carboplatin for Patients With Bilateral Retinoblastoma (RELRB1)
A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)
The investigators are testing subtenon carboplatin in combination with vincristine and topotecan given by vein in the hopes of finding a drug combination that may be effective against retinoblastoma that has come back (recurrent) or is resistant to other treatment (refractory).
The goals of this study are:
- To decide if the drug combination is a useful treatment for recurrent or refractory retinoblastoma
- To test the safety of the drug combination and to see what kind of effects (good and bad) can be expected from the drug combination
- To measure visual changes before and after the study therapy
- To use a special MRI scan to measure brain function involved in vision processing, both before and after the study therapy
In this study, the investigators are also testing a new experimental way of giving carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through a needle placed under the covering of the eye. This is to try to get more carboplatin to the retinoblastoma inside the eye.
調査の概要
状態
条件
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age: ≤ 10 years of age
- Diagnosis: Patients must have a history of bilateral Retinoblastoma AND Recurrent/Refractory Intra-Ocular Retinoblastoma considered not amenable to cure with local therapies alone (photocoagulation with argon laser, cryotherapy, transpupillary thermotherapy, radioactive plaque therapy).
- Therapeutic Options: Patient's disease status is one for which there are no known options proven to provide a high chance for ocular salvage or cure other than external beam radiation or enucleation.
- Remaining visual function in target eye (s) is required
- Life Expectancy of > 8 weeks
- Lansky ≥ 50
- Prior Therapy: Patients must have local relapsed/refractory disease after receiving standard upfront therapy involving at least one chemotherapeutic regimen. There is no limit to prior chemotherapeutic regimens permitted. Patients may have received previous intravenous carboplatin, but may not have received prior subtenon carboplatin or intravenous topotecan.
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, as described below:
- Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of study enrollment
- Biologic therapies: Patients must not have received biologic anti-cancer agents within one week of study enrollment
- Radiation therapy: Four weeks must have elapsed since external beam radiation therapy, if given.
Adequate Bone Marrow Function Defined as:
- Peripheral absolute neutrophil count (ANC) ≥ 750/µL
- Platelet count ≥ 75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
- Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions)
Adequate Renal Function Defined as:
- Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR threshold creatinine values based on age/gender derived from the Schwartz formula for estimating GFR
Adequate Liver Function Defined As:
- Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age
- SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age
- Serum albumin ≥ 2 g/dL
Exclusion Criteria:
- Extra-ocular retinoblastoma
- Asynchronous involvement of the contralateral eye, previously untreated
- Uncontrolled infection at time of protocol entry
Concomitant Medications:
- Growth factors that support platelet or white cell number or function must not have been administered within the past 3 days
- Patients who are currently receiving investigational drugs, or who have received an investigational drug within the last 7 days, are ineligible
- Patients who are currently receiving other anti-cancer agents are ineligible
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Topotecan/Vincristine with subtenon Carboplatin
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Available in 50mg, 150mg, 450 mg, 600mg vials.
It is provided as a premixed aqueous solution or lyophilized powder for injection given on day 1/week 10 (cycles 1-3).
他の名前:
Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base.
Given intravenously on days 1-5 of each week (cycles 1-6).
他の名前:
Each vial contains vincristine sulfate, 1 mg; mannitol, 100 mg; sterile water for injection; Acetic acid and sodium acetate are added for pH control.
Given intravenously on day 1/week 1 (cycles 1-6).
他の名前:
Supplied as a clear solution in 300 mcg/ml 1 ml or 1.6 ml vials and prefilled syringes containing 300mcg/0.5mL
or 480mcg/0.8mL.
Given intravenously on day 6 of each week (cycles 1-6).
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.
時間枠:at 1 year
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at 1 year
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To estimate the patterns of response, and response rate of locally refractory retinoblastoma to combination intravenous and peri-ocular chemotherapy.
時間枠:at 1 yr
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at 1 yr
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二次結果の測定
結果測定 |
時間枠 |
---|---|
To describe the toxicities associated with the proposed regimen.
時間枠:at 1 yr
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at 1 yr
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To describe the histologic findings in the eyes ultimately requiring enucleation.
時間枠:at 1 yr
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at 1 yr
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To describe the visual acuity of patients with advanced intraocular retinoblastoma before and after the proposed therapy.
時間枠:at 1 yr
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at 1 yr
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To describe primary visual cortex function in patients with retinoblastoma via functional Magnetic Resonance Imaging (fMRI) technique both before and after the proposed therapy.
時間枠:at 1 yr
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at 1 yr
|
協力者と研究者
捜査官
- 主任研究者:James Geller, MD、Children's Hospital Medical Center, Cincinnati
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RELRB1
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
subtenon Carboplatinの臨床試験
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
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Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド