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 I or II (N0), defined by all of the following criteria:
-  Favorable site, including orbit, head, and neck (excluding parameningeal
sites), genitourinary region (excluding bladder/prostate sites), or biliary
tract
-  Tumor any size
-  Completely resected disease OR microscopic residual disease
-  Lymph nodes clinically negative
-  Stage I, clinical group III (N0), defined by all of the following criteria:
-  Favorable site
-  Tumor any size
-  Gross residual disease allowed (orbit only)
-  Lymph nodes clinically negative
-  Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
-  Unfavorable site (any sites not listed as favorable sites)
-  Tumor ≤ 5 cm in diameter
-  Completely resected disease
-  Lymph nodes clinically negative OR lymph node involvement unknown
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
-  Must have acceptable organ function for age
-  No uncontrolled infection
-  No other active malignancy
-  No other treated malignancy within the past 5 years
-  No hypersensitivity to study drugs
-  No Charcot-Marie-Tooth disease
-  No chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
-  No prior anticancer chemotherapy
Endocrine therapy
-  Prior anticancer steroids allowed
Radiotherapy
-  No prior radiotherapy
Other
-  No concurrent pentostatin

OBJECTIVES:

-  Determine the progression-free survival rate in patients with low-risk embryonal
rhadomyosarcoma treated with a shortened treatment schedule of vincristine,
dactinomycin, and cyclophosphamide with or without radiotherapy.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients
may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of
24 weeks) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

• Biological: dactinomycin
• Drug: cyclophosphamide
• Drug: vincristine sulfate
• Radiation: radiation therapy

• Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
  Safety Issue: No
• Overall survival as measured by Kaplan-Meier method 3 years after study entry
  Safety Issue: No
• Progression-free survival as measured by Kaplan-Meier method during events
  Safety Issue: No
• Complete response rate (orbit, group III only) at completion of study treatment
  Safety Issue: No
• Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry
  Safety Issue: Yes

• Hajime Hosoi
  Study Chair, Kyoto Prefectural University of Medicine
• Masa-aki Kumagai, MD
  National Center for Child Health and Development

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

  8(123) 628-5329

  tmitsui@med.id.yamagata-u.ac.jp
• Toyama University Hospital
  Toyama, 930-0194, Japan
  Recruiting
  Hirokazu Kanegane

  8(176) 434-7313

  kanegane@ms.toyama-mpu.ac.jp
• St. Luke's International Hospital
  Tokyo, 104, Japan
  Recruiting
  R. Hosoya, MD

  8(133) 541-5151
• National Cancer Center Hospital
  Tokyo, 104-0045, Japan
  Recruiting
  Atsushi Makimoto

  8(133) 542-2511
• Toho University School of Medicine
  Tokyo, 143-8541, Japan
  Recruiting
  Akira Ohara

  8(133) 762-4151
• Keio University School of Medicine
  Tokyo, 160-8582, Japan
  Recruiting
  Yasuhide Morikawa, MD

  8(135) 363-2593

  ymorikaw@sc.itc.keio.ac.jp
• Nihon University Itabashi Hospital
  Tokyo, 173, Japan
  Recruiting
  Hideo Mugishima, MD

  8(133) 972-8111
• Tokyo Medical and Dental University
  Tokyo, 113-8510, Japan
  Recruiting
  Masayuki Nagasawa

  8(135) 803-5246
• 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

• Japan Rhabdomyosarcoma Study Group
  Lead Sponsor
• Unspecified

• Clinical trial summary from the National Cancer Institute's PDQ® database
  http://cancer.gov/clinicaltrials/JRSG-UHA-PED03-01