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Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

This study has been completed.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003958
  Purpose

RATIONALE: Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma.


Condition Intervention Phase
Sarcoma
Drug: cyclophosphamide
Drug: dactinomycin
Drug: filgrastim
Drug: sargramostim
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: radiation therapy
Procedure: surgical procedure
Phase III

MedlinePlus related topics:   Cancer    Soft Tissue Sarcoma   

Drug Information available for:   Cyclophosphamide    Filgrastim    Vincristine sulfate    Vincristine    Topotecan hydrochloride    Topotecan    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Dactinomycin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate-Risk Rhabdomyosarcoma

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

Primary Outcome Measures:
  • Early response rate (ERR) (i.e., complete response/partial response [CR/PR]) at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Failure-free survival (FFS) at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Survival at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Acute and late effects (e.g., sterility, second malignancy, radiation effects, and growth effects) of these regimens continuously for up to 10 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of second-look surgery in patients with bulk residual tumor at diagnosis and those who become "tumor free" or have microscopic tumor only and are treated with reduced dose radiation at the end of therapy [ Designated as safety issue: No ]
  • Rate of local failure in selected patients with bulk residual tumors at diagnosis who undergo second-look resection and response-adjusted radiotherapy dose reduction ongoing for up to 10 years [ Designated as safety issue: No ]
  • Preoperative radiotherapy followed by second-look surgery indicated for patients who respond poorly to induction chemotherapy [ Designated as safety issue: No ]
  • Define and compare clinical features (demographics such as age, disease site and stage, node involvement, or outcome) of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry t(2;13), t(1;13) or neither transloc. at end of the study [ Designated as safety issue: No ]
  • Estimation of ERR, FFS, and survival of patients with alveolar rhabdomyosarcoma with t(2;13), t(1;13), or neither transloc. by pos. or neg. RTPCR on peripheral blood and marrow spec. at diagnosis and at end of tx [ Designated as safety issue: No ]

Estimated Enrollment:   518
Study Start Date:   September 2002

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven disease of any of the following types:

    • Nonmetastatic alveolar rhabdomyosarcoma

      • Stage I, II, or III; Clinical Group I, II, or III
    • Stage II or III, Clinical Group III embryonal rhabdomyosarcoma

      • Botryoid
      • Spindle cell
    • Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma

      • Botryoid
      • Spindle cell
    • Undifferentiated sarcoma

      • Stage I, II, or III; Clinical Group I, II, or III
    • Ectomesenchymoma

      • Stage I, II, or III; Clinical Group I, II, or III, with alveolar features
      • Under 10 years, Stage IV, Clinical Group IV, with embryonal features
  • No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis
  • No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases

PATIENT CHARACTERISTICS:

Age:

  • Under 50

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine normal* for age NOTE: *Patients with tumor obstruction causing creatinine elevation may be enrolled

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003958

Show 233 study locations  Show 233 Study Locations

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Carola A. S. Arndt, MD     Mayo Clinic    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Arndt CA, Hawkins DS, Stoner JA, et al.: Randomized phase III trial comparing vincristine, actinomycin, cyclophosphamide (VAC) with VAC/V topotecan/cyclophosphamide (TC) for intermediate risk rhabdomyosarcoma (IRRMS). D9803, COG study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9509, 528s, 2007.
 
Arndt C, Hawkins D, Anderson JR, Breitfeld P, Womer R, Meyer W. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901. Erratum in: J Clin Oncol. 2004 Aug 15;22(16):3434. Correction of dosage error in text.
 

Other Publications:

Study ID Numbers:   CDR0000067157, COG-D9803, CCG-D9803, POG-D9803, IRS-D9803
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00003958
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
embryonal childhood rhabdomyosarcoma  
alveolar childhood rhabdomyosarcoma  
embryonal-botryoid childhood rhabdomyosarcoma  
nonmetastatic childhood soft tissue sarcoma  
childhood malignant mesenchymoma  
previously untreated childhood rhabdomyosarcoma  
adult rhabdomyosarcoma
adult malignant mesenchymoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage I adult soft tissue sarcoma

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Dactinomycin
Malignant mesenchymal tumor
Sarcoma
Vincristine
Cyclophosphamide
Topotecan
Soft tissue sarcomas
Rhabdomyosarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2008




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