Clinical trial NCT00354744: High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
Official title: Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma
Conditions: Sarcoma
Summary: RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
Interventions:
description: Age based dosage: ≥ 1 year 0.045 mg/kg IV x 1(maximum dose 2.5 mg), < 1 year 0.025 mg/kg.<br/>Day 1 of Weeks 35, 38, 41 and 44.<br/>Given IV
name: dactinomycin
other_name: Actinomycin-D
Cosmegen
NSC #3053
type: Biological
description: Age based dosage: ≥ 3 years 1200 mg/m2, <3 years 40 mg/kg.<br/>Day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 and 44.<br/>Given IV
name: cyclophosphamide
other_name: Cytoxan
NSC #26271
type: Drug
description: Age based dosage: ≥ 1 year: 37.5mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis. Total dose 75 mg/m².<br/>Days 1 and 2 of weeks 7, 11, 15, 28 and 32.<br/>Given IV
name: doxorubicin hydrochloride
other_name: Adriamycin
NSC #123127
type: Drug
description: Age based dosage: ≥ 1 year: 100 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.<br/>Days 1-5 of weeks 9, 13, 17, 26 and 30.<br/>Given IV
name: etoposide
other_name: Etopophos
NSC #141540
VP-16
VePesid
type: Drug
description: Age based dosage: ≥ 1 year: 1800 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.<br/>Days 1-5 of weeks 9, 13, 17, 26 and 30.<br/>Given IV
name: ifosfamide
other_name: Ifex
Iphosphamide
Isophosphamide
NSC #109724
Z4942
type: Drug
description: Dosage 50 mg/m2-max dose 100 mg/day.<br/>Days 1-5 of weeks 1, 4, 20, 23, 47 and 50.<br/>Given IV
name: irinotecan hydrochloride
other_name: 7-ethyl-10-(4-[1-piperidino]-1-piperidino)-carbonyloxy-camptothecin
CPT-11
Camptosar
Camptothecin-11
NSC #616348
type: Drug
description: Age based dosage: ≥ 3 years 1.5 mg/m2 (max dose 2 mg), ≥ 1 year and < 3 years 0.05 mg/kg (max dose 2 mg), < 1 year 0.025 mg/kg.<br/>Days 1-5 of weeks 1, 2, 3, 4, 5, 7, 8, 11, 12, 15, 16, 20, 21, 22, 23, 24, 28, 29, 32, 33, 35, 38, 41, 42, 43, 44, 47, 48, 50, and 51.<br/>Given IV
name: vincristine sulfate
other_name: LCR
NSC #67574
Oncovin
VCR
type: Drug
description: Resection of the primary tumor with a surrounding "envelope" of normal tissue
name: conventional surgery
type: Procedure
description: Radiotherapy beginning at Week 20 to the primary tumor and to the metastatic sites excepting those with parameningeal tumors with intracranial extension (direct extension into the brain) and those requiring emergency radiotherapy
name: radiation therapy
type: Radiation
description: 5 micrograms/kg/day (max 300 micrograms) beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/μL whichever comes last.<br/>Given subcutaneously.
name: filgrastim
other_name: G-CSF
Granulocyte Colony-Stimulating Factor
NSC #614629
Neupogen
r-metHuG-CSF
type: Biological
Study arms:
design_group_description: Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
design_group_title: High Risk Rhabdomyosarcoma
design_group_type: Experimental
Sponsor: The Children's Oncology Group Foundation, Inc.
Collaborators: National Cancer Institute
Drug name mappings:
name: 依托泊苷
lang: CN
name: Etoposide
lang: EN
name: エトポシド
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 非格司亭 （安进）
lang: CN
name: Filgrastim (Amgen)
lang: EN
name: フィルグラスチム（遺伝子組換え）
lang: JP
name: 盐酸多柔比星
lang: CN
name: Doxorubicin Hydrochloride
lang: EN
name: ドキソルビシン塩酸塩
lang: JP
name: 放线菌素D
lang: CN
name: Dactinomycin
lang: EN
name: アクチノマイシン D
lang: JP
name: 异环磷酰胺
lang: CN
name: Ifosamide
lang: EN
name: イホスファミド
lang: JP
name: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
lang: JP
name: 硫酸长春新碱
lang: CN
name: Vincristine Sulfate
lang: EN
name: ビンクリスチン硫酸塩
lang: JP