Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma - Full Text View

Sponsor:	Japan Rhabdomyosarcoma Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00245089

Purpose

RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.

Condition	Intervention	Phase
Sarcoma	Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival at 3 years after study registration [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival at 3 years after study registration [ Designated as safety issue: No ]
Toxicity by NCI CTC at 3 years after study registration [ Designated as safety issue: Yes ]

Estimated Enrollment:	41
Study Start Date:	May 2004
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the progression-free survival rate in patients with low-risk embryonal rhabdomyosarcoma treated with intensive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide followed by vincristine and dactinomycin.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vincristine IV and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of embryonal rhabdomyosarcoma
- Primary operation for pathological diagnosis within the past 42 days
- The following variants are eligible:
  - Botryoid
  - Spindle cell
  - Anaplastic
Meets 1 of the following stage criteria:
- Stage I, clinical group II (N1)
  - Favorable site
  - Any tumor size
  - Microscopic residual disease
  - Lymph nodes clinically positive
- Stage I, clinical group III (N1)
  - Favorable site (orbit only)
  - Any tumor size
  - Gross residual disease
  - Lymph nodes clinically positive
- Stage I, clinical group III (N0, NX, N1)
  - Favorable site (except orbit)
  - Any tumor size
  - Gross residual disease
  - Lymph nodes clinically negative, involvement unknown, or positive
- Stage II, clinical group II (N0, NX)
  - Unfavorable site
  - Small tumor (≤ 5 cm in diameter)
  - Microscopic residual disease
- Stage III, clinical group I or II (N0, NX, N1)
  - Unfavorable site
  - Small tumor (≤ 5 cm in diameter) with positive nodes or large tumor (> 5 cm in diameter) with any lymph nodes status
  - Completely resected or microscopic residual disease

PATIENT CHARACTERISTICS:

Performance status

Life expectancy

Not specified

Hematopoietic

WBC ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 7.5 g/dL

Hepatic

SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2.5 times ULN
Bile acid ≤ 2.5 times ULN

Renal

Creatinine based on age as follows:
- ≤ 0.8 mg/dL (for patients < 5 years of age)
- ≤ 1.2 mg/dL (for patients 5-9 years of age)
- ≤ 1.5 mg/dL (for patients ≥ 10 years of age)

Cardiovascular

No severe heart disease

Other

Not pregnant or nursing
No uncontrolled infection
Must have acceptable organ function for age
No other malignancy within the past 5 years
No hypersensitivity attributed to study drugs
No Charcot-Marie-Tooth disease or chickenpox

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior anticancer chemotherapy

Endocrine therapy

Prior anticancer steroids allowed

Radiotherapy

Prior emergency radiotherapy allowed within the past 2 weeks

Other

No concurrent pentostatin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245089

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Locations

Japan
Hokkaido Medical Center for Child Health and Rehabilitation	Recruiting
Sapporo, Japan, 006-0041
Contact: Tooru Kudoh, MD, PhD 81-11-691-5696
Fukushima Medical University Hospital	Recruiting
Fukushima, Japan, 960-1295
Contact: Atsushi Kikuta, MD 81-24-547-1295
Gifu University Graduate School of Medicine	Recruiting
Gifu, Japan, 500-8705
Contact: Hideo Kaneko 81-58-230-6386
Hiroshima University Hospital	Recruiting
Hiroshima, Japan, 734-8551
Contact: Nishimura Shinichiro, MD 81-82-257-5212
Kagoshima University	Recruiting
Kagoshima, Japan, 890-8520
Contact: Yoshifumi Kawano 81-99-275-5351 ykawano@m3.kufm.kagoshima-u.ac.jp
Kyoto Prefectural University of Medicine	Recruiting
Kyoto, Japan, 602-8566
Contact: Hajime Hosoi 81-75-251-5571 hhosoi@koto.kpu-m.ac.jp
National Cancer Center Hospital	Recruiting
Tokyo, Japan, 104-0045
Contact: Atsushi Makimoto 81-3-3542-2511
Osaka City University	Recruiting
Osaka, Japan, 545-8586
Contact: Kazumi Yamato 81-6-6645-3175
Osaka General Medical Center	Recruiting
Osaka, Japan, 558-0056
Contact: Keiko Yumura-Yagi, MD 81-6-6692-1201
Saitama Children's Medical Center	Recruiting
Saitama, Japan, 339-8551
Contact: Akira Kikuchi, MD, PhD 81-48-758-1811 a1091069@pref.saitama.jp
Keio University School of Medicine	Recruiting
Tokyo, Japan, 160-8582
Contact: Yasuhide Morikawa, MD 81-3-5363-2593 ymorikaw@sc.itc.keio.ac.jp
Kyoto University Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Kenichiro Watanabe, MD 81-75-751-3297 wataken@kuhp.kyoto-u.ac.jp
Nihon University Itabashi Hospital	Recruiting
Tokyo, Japan, 173
Contact: Hideo Mugishima, MD 81-3-3972-8111 ext. 2700
St. Luke's International Hospital	Recruiting
Tokyo, Japan, 104
Contact: R. Hosoya, MD 81-3-3541-5151
Toho University School of Medicine	Recruiting
Tokyo, Japan, 143-8541
Contact: Akira Ohara 81-3-3762-4151
Tokyo Medical and Dental University	Recruiting
Tokyo, Japan, 113-8510
Contact: Masayuki Nagasawa 81-3-5803-5246
Yamagata University Hospital	Recruiting
Yamagata, Japan, 990-9585
Contact: Mitsui Tetsuo, MD, DMedSci 81-23-628-5329 tmitsui@med.id.yamagata-u.ac.jp
Japan, Aichi
Aichi Medical University	Recruiting
Nagakuti, Aichi, Japan, 480-1103
Contact: Toshinori Hori 81-561-62-3311
Anjo Kosei Hosptial	Recruiting
Anjo, Aichi, Japan, 446-8602
Contact: Yuji Miyajima, MD 81-566-75-2111 miyajima@kosei.anjo.aichi
National Hospital Orgnization Nagoya Medical Center	Recruiting
Nagoya, Aichi, Japan, 460-0001
Contact: Keizo Horibe, MD, PhD 81-52-951-1111 horibek@nnh.hosp.go.jp
Japan, Ehime
Ehime Prefectural Central Hospital	Recruiting
Matsuyama-shi, Ehime, Japan, 790-0024
Contact: Otoh Yoshiko 81-89-947-1111
Japan, Fukuoka
Kurume University School of Medicine	Recruiting
Kurume City, Fukuoka, Japan, 830-0011
Contact: Hiroko Inada 81-942-31-7565
National Kyushu Cancer Center	Recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Contact: Ryohei Yokoyama, MD 81-92-541-3231 ext. 5070 ryokoya@nk-cc.go.jp
Japan, Gifu
Gifu Municipal Hospital	Recruiting
Gifu-shi, Gifu, Japan, 500-8513
Contact: Akira Takao, MD 81-58-251-1101 oyuki@gmhosp.gifu.gifu.jp
Japan, Gunma
Gunma Children's Medical Center	Recruiting
Seta-gun, Gunma, Japan, 377-8577
Contact: Manabu Sotomatsu, MD 81-279-52-3551 sotomatsu@gcmc.pref.gunma.jp
Japan, Hiroshima
National Hospital Organization - Medical Center of Kure	Recruiting
Kure, Hiroshima, Japan, 737-0023
Contact: Takeo Tanaka, MD, PhD 81-82-322-3111
Japan, Hokkaido
Hokkaido University Graduate School of Medicine	Recruiting
Sapporo, Hokkaido, Japan, 060-8638
Contact: Ryoji Kobayashi, MD 81-11-706-5954
Sapporo Medical University	Recruiting
Sapporo, Hokkaido, Japan, 060-8556
Contact: Nobuhiro Suzuki, MD, PhD 81-11-611-2111
Japan, Hyogo
Kobe City General Hospital	Recruiting
Kobe, Hyogo, Japan, 650
Contact: Ikuya Usami 81-78-302-4321
Japan, Ibaraki
Ibaraki Children's Hospital	Recruiting
Mito-shi, Ibaraki, Japan, 311-4145
Contact: Kazutoshi Koike 81-29-254-1151 kazukoike@ibaraki-kodomo.com
University of Tsukuba	Recruiting
Tsukuba-city, Ibaraki, Japan, 305-8575
Contact: Michio Kaneko, MD, PhD 81-29-853-3094 mkaneko@md.tsukuba.ac.jp
Japan, Ishikawa
Ishikawa Prefectural Central Hospital	Recruiting
Kanazawa-shi, Ishikawa, Japan, 920-02
Contact: Seiki Horita 81-76-237-8211 shorita@ipch.jp
Kanazawa Medical University	Recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Contact: Yutaka Saikawa, MD, PhD 81-76-265-2314 saikawa@ped.m.kanazawa-u.ac.jp
Japan, Kagoshima
Kagoshima City Hospital	Recruiting
Kagoshima City, Kagoshima, Japan, 892-8580
Contact: Kiyoshi Kawakami 81-99-224-2101
Japan, Kanagawa
National Center for Child Health and Development	Recruiting
Tokyo, Kanagawa, Japan, 157-8535
Contact: Masa-aki Kumagai, MD 81-3-3416-0181 kumagai-ma@ncchd.go.jp
Showa University Fujigaoka Hospital	Recruiting
Yokohama-shi, Kanagawa, Japan, 227-8502
Contact: K. Isoyama 81-45-971-1151 isoyama@syowa-univesity-fujigaoka.gr.jp
Yokohama City University	Recruiting
Yokohama, Kanagawa, Japan, 236-0004
Contact: Hiroaki Goto 81-45-787-2800
Japan, Miyazaki
Miyazaki Medical College University of Miyazaki	Recruiting
Miyazaki-gun, Miyazaki, Japan, 889-1692
Contact: Hiroshi Moritake 81-98-585-0989
Japan, Nagano
Nagano Children's Hospital	Recruiting
Toyoshina-machi, Nagano, Japan, 399-8288
Contact: Eizaburo Ishii 81-263-73-6700
Japan, Osaka
Osaka City General Hospital	Recruiting
Suita-shi, Osaka, Japan, 565-0871
Contact: Junichi Hara 81-6-6929-1221
Osaka Medical Center and Research Institute for Maternal and Child Health	Recruiting
Izumi, Osaka, Japan, 594-1101
Contact: Keisei Kawa, MD, PhD 81-725-56-1220 kawakei@mch.pref.osaka.jp
Osaka Medical College	Recruiting
Takatsuki City, Osaka, Japan, 569-8686
Contact: Tomoko Kuno 81-72-683-1221
Osaka University Graduate School of Medicine	Recruiting
Suita-shi, Osaka, Japan, 565-0871
Contact: Hideaki Ohta, MD, PhD 81-6-6879-3937 ohta@ped.med.osaka-u.ac.jp
Japan, Saitama
Dokkyo University School of Medicine	Recruiting
Koshigaya, Saitama, Japan, 343-8555
Contact: Hitoshi Ikeda, MD 81-489-65-1111 hike@dokkyomed.ac.jp
National Defense Medical College	Recruiting
Tokorozawa, Saitama, Japan, 359-8513
Contact: Kazuhiro Kogawa 81-4-2995-1621
Japan, Shiga
Shiga University of Medical Science	Recruiting
Otsu-shi, Shiga, Japan, 520-21
Contact: Shigeru Ohta, MD 81-775-48-2228 ohta@belle.shiga-med.ac.jp
Japan, Shimane
Shimane University Hospital	Recruiting
Izumo, Shimane, Japan, 693-8501
Contact: Ken Taketani, MD 81-853-20-2219 ttaketani@med.shimane-u.ac.jp
Japan, Shizuoka
Seirei Hamamatsu General Hospital	Recruiting
Hamamatsu, Shizuoka, Japan, 430-8558
Contact: Tadashi Matsubayashi 81-53-474-2222

Sponsors and Collaborators

Japan Rhabdomyosarcoma Study Group

Investigators

Study Chair:	Hajime Hosoi	Kyoto Prefectural University of Medicine
Investigator:	Ryoji Hanada, MD	Saitama Children's Medical Center
Investigator:	Keizo Horibe, MD, PhD	National Hospital Orgnization Nagoya Medical Center

Study ID Numbers:	CDR0000450162, JRSG-UHA-PED03-02
Study First Received:	October 25, 2005
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00245089 History of Changes
Health Authority:	Unspecified