Medpedia

• Sarcoma

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
-  0-3
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

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.

• Biological: dactinomycin
• Drug: cyclophosphamide
• Drug: vincristine sulfate

• Disease-free survival at 3 years after study registration
  Safety Issue: No
• Overall survival at 3 years after study registration
  Safety Issue: No
• Toxicity by NCI CTC at 3 years after study registration
  Safety Issue: Yes

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

• Yamagata University Hospital
  Yamagata, 990-9585, Japan
  Recruiting
  Mitsui Tetsuo, MD, DMedSci

  8(123) 628-5329

  tmitsui@med.id.yamagata-u.ac.jp
• Tokyo Medical and Dental University
  Tokyo, 113-8510, Japan
  Recruiting
  Masayuki Nagasawa

  8(135) 803-5246
• Toho University School of Medicine
  Tokyo, 143-8541, Japan
  Recruiting
  Akira Ohara

  8(133) 762-4151
• St. Luke's International Hospital
  Tokyo, 104, Japan
  Recruiting
  R. Hosoya, MD

  8(133) 541-5151
• Nihon University Itabashi Hospital
  Tokyo, 173, Japan
  Recruiting
  Hideo Mugishima, MD

  8(133) 972-8111
• National Cancer Center Hospital
  Tokyo, 104-0045, Japan
  Recruiting
  Atsushi Makimoto

  8(133) 542-2511
• Keio University School of Medicine
  Tokyo, 160-8582, Japan
  Recruiting
  Yasuhide Morikawa, MD

  8(135) 363-2593

  ymorikaw@sc.itc.keio.ac.jp
• Hokkaido Medical Center for Child Health and Rehabilitation
  Sapporo, 006-0041, Japan
  Recruiting
  Tooru Kudoh, MD, PhD

  8(111) 691-5696
• Saitama Children's Medical Center
  Saitama, 339-8551, Japan
  Recruiting
  Akira Kikuchi, MD, PhD

  8(148) 758-1811

  a1091069@pref.saitama.jp
• Osaka City University
  Osaka, 545-8586, Japan
  Recruiting
  Kazumi Yamato

  8(166) 645-3175
• Osaka General Medical Center
  Osaka, 558-0056, Japan
  Recruiting
  Keiko Yumura-Yagi, MD

  8(166) 692-1201
• Kyoto Prefectural University of Medicine
  Kyoto, 602-8566, Japan
  Recruiting
  Hajime Hosoi

  8(175) 251-5571

  hhosoi@koto.kpu-m.ac.jp

• Japan Rhabdomyosarcoma Study Group
  Lead Sponsor
• Unspecified

• Clinical trial summary from the National Cancer Institute's PDQ® database
  http://cancer.gov/clinicaltrials/JRSG-UHA-PED03-02