Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
A Phase I Study of Thrombopoietin (rhTPO) Plus G-CSF in Children Receiving Ifosfamide, Carboplatin, and Etoposide (I.C.E.) Chemotherapy for Recurrent or Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide, carboplatin, and etoposide (ICE).
- Determine a safe dose of recombinant human thrombopoietin with filgrastim (G-CSF) in this patient population.
- Evaluate the time to platelet count recovery following chemotherapy in this patient population.
- Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population.
OUTLINE: This is a dose escalation study of recombinant human thrombopoietin.
All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days.
Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33.
PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Long Beach、California、アメリカ、90806
- Long Beach Memorial Medical Center
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、アメリカ、91010
- Beckman Research Institute, City of Hope
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Los Angeles、California、アメリカ、90027-0700
- Children's Hospital Los Angeles
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Orange、California、アメリカ、92668
- Children's Hospital of Orange County
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San Francisco、California、アメリカ、94115-0128
- UCSF Cancer Center and Cancer Research Institute
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District of Columbia
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Washington、District of Columbia、アメリカ、20010-2970
- Children's National Medical Center
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Indiana
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Indianapolis、Indiana、アメリカ、46202-5265
- Indiana University Cancer Center
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0752
- University of Michigan Comprehensive Cancer Center
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Cancer Center
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Missouri
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Kansas City、Missouri、アメリカ、64108
- Children's Mercy Hospital - Kansas City
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New York
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
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New York、New York、アメリカ、10016
- Kaplan Cancer Center
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New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center
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Ohio
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Cincinnati、Ohio、アメリカ、45229-3039
- Children's Hospital Medical Center - Cincinnati
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Pittsburgh、Pennsylvania、アメリカ、15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville、Tennessee、アメリカ、37232-6838
- Vanderbilt Cancer Center
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Texas
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Houston、Texas、アメリカ、77030
- University of Texas - MD Anderson Cancer Center
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Utah
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Salt Lake City、Utah、アメリカ、84132
- Huntsman Cancer Institute
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Washington
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Seattle、Washington、アメリカ、98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Comprehensive Cancer Center
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Western Australia
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Perth、Western Australia、オーストラリア、6001
- Princess Margaret Hospital for Children
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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
DISEASE CHARACTERISTICS: Histologically proven (except for brain stem tumors) malignancy that has
failed or relapsed after standard first-line antineoplastic therapy
- Sarcoma (soft tissue and bone)
- Kidney tumors
- Brain tumors
- Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
- retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks
No bone marrow involvement
No prior or concurrent myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
- 1 to 21
Performance status:
- Lansky or Karnofsky 60-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1000/mm3
- Platelet count greater than 100,000/mm3
- No grade III or IV thrombosis
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 2.5 times ULN
Renal:
- Creatinine clearance or glomerular filtration rate at least 70 mL/min
Cardiovascular:
- Ejection fraction normal
- No evidence of arrhythmias requiring therapy
- Fractional shortening greater than 28%
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 10 days since prior colony-stimulating factor therapy and recovered
- At least 30 days since prior epoetin alfa
- No other concurrent cytokines, including epoetin alfa
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and
- recovered
- At least 3 months since therapy with etoposide, carboplatin, or ifosfamide
- that is identical to study treatment
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy allowed after third course of therapy
- No prior cranial/spinal radiotherapy
- No prior radiotherapy to greater than 50% of bone marrow
Surgery:
- Concurrent surgery allowed after the second course of therapy
Other:
- No concurrent investigational agents
- No concurrent lithium, aspirin, coumadin, or heparin
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：支持療法
- 割り当て：非ランダム化
- 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 |
|---|---|
|
実験的：Cohort 1
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5.
All patients receive recombinant human thrombopoietin (rhTPO).
rhTPO began on the last day of ICE (Ifosfamide, Carboplatin and Etoposide) chemotherapy (Day 4) and subsequent doses will be administered on Days 6, 8, 10 and 12 (5 doses total).
The initial dose of rhTPO was 1.2 μg/kg/dose and was subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated.
Therapy will continue for maximum six courses.
Pharmacokinetic data will be obtained (during course one only).
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他の名前：
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実験的：Cohort 2
Chemotherapy days 0-4, G-CSF (5 μg/kg/d) as a daily subcutaneous injection beginning on Day 5. All patients receive recombinant human thrombopoietin (rhTPO). The dose of rhTPO 1.2 μg/kg/dose and subsequently escalated to 2.4 and 3.6 μg/kg/dose as tolerated. Patients assigned to Cohort II will receive pre-chemotherapy rhTPO at 3.6 μg/kg/dose on Days -5, -3, -1, and post-chemotherapy rhTPO on Days +4, +6, and +8 (6 doses total. Subsequent courses of chemotherapy will begin as soon as the ANC recovers to ≥ 1,000/μL and the platelet count to ≥ 100,000/μL between days 21 and 35. Therapy will continue for maximum six courses. Pharmacokinetic data will be obtained (during course one nly). For the second cohort, full data collection will occur for cycles one and two and limited data collection for cycles 3, 4, 5, and 6. |
他の名前：
他の名前：
他の名前：
他の名前：
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO)
時間枠：length of study
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To determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin (rhTPO) in children receiving I.C.E.
myelosuppressive chemotherapy.
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length of study
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluate the time for patients to demonstrate platelet recovery
時間枠：Length of study
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To evaluate the time for patients to demonstrate platelet recovery following I.C.E.
chemotherapy with rhTPO + G-CSF.
|
Length of study
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協力者と研究者
捜査官
- スタディチェア：Mitchell S. Cairo, MD、Herbert Irving Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
キーワード
- 再発腎細胞がん
- 詳細不明の小児固形腫瘍、プロトコル固有
- 好中球減少症
- 再発性黒色腫
- 再発性眼内黒色腫
- 血小板減少症
- 再発小児横紋筋肉腫
- 再発神経芽腫
- 再発子宮肉腫
- 再発性卵巣胚細胞腫瘍
- 再発悪性精巣胚細胞腫瘍
- 再発ユーイング肉腫/末梢原始神経外胚葉性腫瘍
- 再発性骨肉腫
- 再発性ウィルムス腫瘍およびその他の小児腎腫瘍
- 再発小児テント上原始神経外胚葉性腫瘍
- 再発小児小脳星細胞腫
- 再発小児脳星細胞腫
- 性腺外胚細胞腫瘍
- 再発小児肝がん
- 再発小児軟部肉腫
- 再発性小児脳幹グリオーマ
- 再発性小児髄芽腫
- 小児中枢神経系胚細胞腫瘍
- 小児胚細胞腫瘍
- 再発性網膜芽細胞腫
- 再発性妊娠性絨毛腫瘍
- 再発性小児視覚経路神経膠腫
追加の関連 MeSH 用語
その他の研究ID番号
- 09717
- CCG-09717
- CDR0000066668
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