Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

August 9, 2013 updated by: Japan Rhabdomyosarcoma Study Group

Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

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. Radiation therapy uses high energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital
      • Gifu, Japan, 500-8705
        • Recruiting
        • Gifu University Graduate School of Medicine
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
      • Kyoto, Japan, 602-8566
        • Recruiting
        • Kyoto Prefectural University of Medicine
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka City University
      • Osaka, Japan, 558-0056
        • Recruiting
        • Osaka General Medical Center
      • Saitama, Japan, 339-8551
        • Recruiting
        • Saitama Children's Medical Center
      • Sapporo, Japan, 006-0041
        • Recruiting
        • Hokkaido Medical Center for Child Health and Rehabilitation
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
      • Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University School of Medicine
      • Tokyo, Japan, 104
        • Recruiting
        • St. Luke's International Hospital
      • Tokyo, Japan, 113-8510
        • Recruiting
        • Tokyo Medical and Dental University
      • Tokyo, Japan, 143-8541
        • Recruiting
        • Toho University School of Medicine
      • Tokyo, Japan, 173
        • Recruiting
        • Nihon University Itabashi Hospital
      • Toyama, Japan, 930-0194
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
    • Aichi
      • Anjo, Aichi, Japan, 446-8602
        • Recruiting
        • Anjo Kosei Hosptial
      • Nagakuti, Aichi, Japan, 480-1103
        • Recruiting
        • Aichi Medical University
      • Nagoya, Aichi, Japan, 460-0001
        • Recruiting
        • National Hospital Orgnization Nagoya Medical Center
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-0024
        • Recruiting
        • Ehime Prefectural Central Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Recruiting
        • National Kyushu Cancer Center
      • Kurume City, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University School of Medicine
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Recruiting
        • Gifu Municipal Hospital
    • Gunma
      • Seta-gun, Gunma, Japan, 377-8577
        • Recruiting
        • Gunma Children's Medical Center
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • Recruiting
        • National Hospital Organization - Medical Center of Kure
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8556
        • Recruiting
        • Sapporo Medical University
      • Sapporo, Hokkaido, Japan, 060-8638
        • Recruiting
        • Hokkaido University Graduate School of Medicine
    • Hyogo
      • Kobe, Hyogo, Japan, 650
        • Recruiting
        • Kobe City General Hospital
    • Ibaraki
      • Mito-shi, Ibaraki, Japan, 311-4145
        • Recruiting
        • Ibaraki Children's Hospital
      • Tsukuba-city, Ibaraki, Japan, 305-8575
        • Recruiting
        • University of Tsukuba
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa Medical University
      • Kanazawa-shi, Ishikawa, Japan, 920-02
        • Recruiting
        • Ishikawa Prefectural Central Hospital
    • Kagoshima
      • Kagoshima City, Kagoshima, Japan, 892-8580
        • Recruiting
        • Kagoshima City Hospital
    • Kanagawa
      • Tokyo, Kanagawa, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University
      • Yokohama-shi, Kanagawa, Japan, 227-8502
        • Recruiting
        • Showa University Fujigaoka Hospital
    • Miyazaki
      • Miyazaki-gun, Miyazaki, Japan, 889-1692
        • Recruiting
        • Miyazaki Medical College University of Miyazaki
    • Nagano
      • Toyoshina-machi, Nagano, Japan, 399-8288
        • Recruiting
        • Nagano Children's Hospital
    • Osaka
      • Izumi, Osaka, Japan, 594-1101
        • Recruiting
        • Osaka Medical Center and Research Institute for Maternal and Child Health
      • Suita-shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka City General Hospital
      • Suita-shi, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Graduate School of Medicine
      • Takatsuki City, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medical College
    • Saitama
      • Koshigaya, Saitama, Japan, 343-8555
        • Recruiting
        • Dokkyo University School of Medicine
      • Tokorozawa, Saitama, Japan, 359-8513
        • Recruiting
        • National Defense Medical College
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-21
        • Recruiting
        • Shiga University of Medical Science
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital
      • Izumo, Shimane, Japan, 693-0068
        • Recruiting
        • Shimane Prefectural Central Hospital
        • Contact:
          • Ken Taketani, MD
          • Phone Number: 81-853-20-2219
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
        • Recruiting
        • Seirei Hamamatsu General Hospital
    • Tokyo
      • Kiyosei, Tokyo, Japan, 204-8567
        • Recruiting
        • Tokyo Metropolitan Kiyose Children's Hospital
        • Contact:
          • Takashi Kaneko, MD
          • Phone Number: 81-424-91-0011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Secondary Outcome Measures

Outcome Measure
Overall survival as measured by Kaplan-Meier method 3 years after study entry
Progression-free survival as measured by Kaplan-Meier method during events
Complete response rate (orbit, group III only) at completion of study treatment
Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Rhabdomyosarcoma Study Group

Investigators

  • Masa-aki Kumagai, MD, National Center for Child Health and Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JRSG-UHA-PED03-01
  • CDR0000453316 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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