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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

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ClinicalTrials.gov Identifier: NCT00003955
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 14, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: dactinomycin Biological: filgrastim Biological: pegfilgrastim Biological: sargramostim Drug: cyclophosphamide Drug: irinotecan hydrochloride Drug: vincristine sulfate Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response.
  • Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy.
  • Determine the pharmacokinetics of irinotecan and vincristine in these patients.


  • Upfront window therapy: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B.

    • Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22.
    • Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A.

Patients who do not receive upfront window irinotecan/vincristine therapy are treated with standard therapy.

  • Standard therapy: Patients receive vincristine IV over 1 minute weekly on weeks 0-13, 15-19, 23-27, 29, 32-35, 38, and 41; dactinomycin IV over 1 minute weekly on weeks 0, 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients without evidence of intracranial extension receive radiotherapy once daily, 5 days a week, during weeks 15-22. Patients with evidence of intracranial extension, or who require emergency radiotherapy, receive radiotherapy during weeks 0-6. Dactinomycin is withheld during radiotherapy.

All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover. Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover.

Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study
Study Start Date : September 1999
Primary Completion Date : January 2005
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Event Free Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma

    • No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site
    • Metastatic tumors of parameningeal sites eligible
  • Bidimensionally measurable disease
  • No positive cerebrospinal fluid cytology or multiple intracranial metastases
  • Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:

    • Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy
    • Tumor that touches or displaces the spinal cord
    • Evidence of intracranial primary tumor extension
    • Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate
    • Requires emergency radiotherapy
    • Lab values are consistent with disseminated intravascular coagulation



  • Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)
  • 10 to 49 (embryonal histology patients)

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,000/mm^3*
  • Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow


  • Bilirubin less than 1.5 mg/dL
  • PT, PTT, and fibrinogen less than 1.5 times upper limit of normal


  • Creatinine less than 1.2 mg/dL


  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed


  • See Disease Characteristics
  • No prior radiotherapy


  • No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis

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): NCT00003955

  Show 237 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Alberto S. Pappo, MD Texas Children's Cancer Center

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003955     History of Changes
Other Study ID Numbers: D9802
COG-D9802 ( Other Identifier: Children's Oncology Group )
IRS-D9802 ( Other Identifier: Intergroup Rhabdosarcoma Group )
CCG-D9802 ( Other Identifier: Children's Cancer Group )
POG-D9802 ( Other Identifier: Pediatric Oncology Group )
CDR0000067154 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 14, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
metastatic childhood soft tissue sarcoma
childhood malignant mesenchymoma
previously untreated childhood rhabdomyosarcoma
adult rhabdomyosarcoma
adult malignant mesenchymoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
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
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic