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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245141
First Posted: October 27, 2005
Last Update Posted: August 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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. 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.


Condition Intervention Phase
Sarcoma Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245141


  Show 51 Study Locations
Sponsors and Collaborators
Japan Rhabdomyosarcoma Study Group
Investigators
Study Chair: Hajime Hosoi Kyoto Prefectural University of Medicine
OverallOfficial: Masa-aki Kumagai, MD National Center for Child Health and Development
  More Information

ClinicalTrials.gov Identifier: NCT00245141     History of Changes
Other Study ID Numbers: JRSG-UHA-PED03-01
CDR0000453316 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Last Update Posted: August 12, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
embryonal childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma

Additional relevant MeSH terms:
Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Cyclophosphamide
Vincristine
Dactinomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Protein Synthesis Inhibitors
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors