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Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT00003958
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2002
Actual Primary Completion Date : October 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Long-term failure-free survival (FFS) between the two treatment groups [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival between treatments [ Time Frame: Up to 5 years ]
  2. Rate of second look surgery [ Time Frame: Week 12 ]
  3. Proportion of patients rendered tumor-free or with microscopic tumor only [ Time Frame: Week 12 ]
  4. Estimation of the rate of local failure for the patients who undergo second look surgery [ Time Frame: Week 12 ]
    Done using standard cumulative incidence curves.


Eligibility Criteria
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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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): NCT00003958


Locations
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United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carola Arndt Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003958     History of Changes
Other Study ID Numbers: D9803
NCI-2012-02302 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRS-D9803 ( Other Identifier: Intergroup Rhabdosarcoma Group )
COG-D9803 ( Other Identifier: Children's Oncology Group )
POG-D9803 ( Other Identifier: Pediatric Oncology Group )
CDR0000067157 ( Other Identifier: Clinical Trials.gov )
CCG-D9803 ( Other Identifier: Children's Cancer Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Mesenchymoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Complex and Mixed
Dactinomycin
Cyclophosphamide
Vincristine
Topotecan
Lenograstim
 Sargramostim
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
Adjuvants, Immunologic