Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003958
First received: November 1, 1999
Last updated: June 13, 2013
Last verified: June 2013
  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. 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.


Condition Intervention Phase
Adult Malignant Mesenchymoma
Adult Rhabdomyosarcoma
Alveolar Childhood Rhabdomyosarcoma
Childhood Malignant Mesenchymoma
Embryonal Childhood Rhabdomyosarcoma
Embryonal-botryoid Childhood Rhabdomyosarcoma
Nonmetastatic Childhood Soft Tissue Sarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Stage I Adult Soft Tissue Sarcoma
Stage II Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Biological: dactinomycin
Drug: vincristine sulfate
Drug: cyclophosphamide
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Drug: topotecan hydrochloride
Biological: filgrastim
Biological: sargramostim
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Long-term failure-free survival (FFS) between the two treatment groups [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival between treatments [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Rate of second look surgery [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients rendered tumor-free or with microscopic tumor only [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Estimation of the rate of local failure for the patients who undergo second look surgery [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Done using standard cumulative incidence curves.


Enrollment: 702
Study Start Date: September 2002
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Vincristine sulfate IV once a wk on wks 0-12, 15, 18-24, 27, 30-36, and 39. Dactinomycin IV once a wk on wks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV once a wk on wks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and 39. After 12 weeks of chemotherapy, depending on tumor shrinkage, pts may undergo surgery. After recovery from therapeutic conventional surgery, patients receive radiation therapy once a day, 5 days a wk, during wks 12-18. For pt receiving radiotherapy during wks 0-6, dactinomycin is omitted during wks 3 and 6 and during wks 15 and 18. For patients receiving radiotherapy during wks 12-18, dactinomycin is omitted during wks 15 and 18. Patients with adequate response at wk 24 continue chemotherapy during wks 24-39. All pts receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.
Biological: dactinomycin
Given IV
Other Names:
  • ACT-D
  • actinomycin C1
  • AD
  • Cosmegen
  • DACT
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Procedure: therapeutic conventional surgery
Undergo surgery
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Biological: sargramostim
Given SC
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II

Patients receive treatment as in arm I, except dactinomycin is replaced with topotecan hydrochloride IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39.

All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.

Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Procedure: therapeutic conventional surgery
Undergo surgery
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Drug: topotecan hydrochloride
Given IV
Other Names:
  • hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • TOPO
Biological: filgrastim
Given SC
Other Names:
  • G-CSF
  • Neupogen
Biological: sargramostim
Given SC
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Histologically proven disease of any of the following types:

    • Non metastatic 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
  • Bilirubin no greater than 1.5 mg/dL
  • Creatinine normal* for age
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior chemotherapy
  • Prior steroids allowed
  • No prior radiotherapy
  • See Disease Characteristics
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Carola Arndt Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003958     History of Changes
Other Study ID Numbers: D9803, NCI-2012-02302, IRS-D9803, COG-D9803, POG-D9803, CDR0000067157, CCG-D9803, U10CA098543
Study First Received: November 1, 1999
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesenchymoma
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Sarcoma
Liver Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Dactinomycin
Cyclophosphamide
Vincristine
Topotecan
Lenograstim
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 20, 2014