Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	6 months to under 18	Other	SIOP-MMT-98 SFOP-SIOP-MMT-98, CCLG-SIOP-MMT-98, EU-20126, NCT00025441, STS-1998

Objectives

1. Determine the overall survival of children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors treated with one of two different chemotherapy regimens based upon risk group.
2. Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children.
3. Determine the value of a therapeutic window in high-risk children.
4. Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children.
5. Determine the complete response, overall survival, and event-free survival in high-risk children.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic rhabdomyosarcoma or other malignant mesenchymal tumors
  • Standard risk defined as:
    • Less than 10 years of age
    • No bone or bone marrow involvement
  • High risk defined as:
    • At least 10 years of age

      OR

    • Bone or bone marrow involvement



• Diagnosed less than 8 weeks ago



• Previously untreated disease except for initial surgery within the past 8 weeks

Prior/Concurrent Therapy:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No prior endocrine therapy

Radiotherapy:

• Concurrent radiotherapy allowed

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 6 months to under 18 years

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 8-30 standard-risk patients will be accrued for this study within 4 years. A total of 15-75 high-risk patients will be accrued for this study within 4-5 years.

Outline

This is a multicenter study. Patients are stratified according to risk group (standard vs high).

Standard-risk patients:

• Initial chemotherapy: Patients receive vincristine IV on day 1 for weeks 1-7. Patients also receive dactinomycin IV on day 1 and ifosfamide IV over 1 hour on days 1-3 of week 1. Patients then receive carboplatin IV over 1 hour and epirubicin IV over 6 hours on day 1 of week 4. Patients then receive ifosfamide IV over 1 hour and etoposide IV over 4 hours on days 1-3 of week 7. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with less than 50% partial response (PR) are removed from study.

  Patients with parameningeal disease undergo radiotherapy 5 days a week for about 8 weeks beginning at week 9.




• Maintenance chemotherapy: Patients receive cyclophosphamide IV over 1 hour, vincristine IV, and dactinomycin IV on day 1. Treatment repeats every 3 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

  Patients who remain in PR at week 17 undergo radiotherapy for about 9 weeks beginning at week 18.

High-risk patients:

• Initial chemotherapy: Patients receive window study drug carboplatin IV over 1 hour or doxorubicin on day 1. Treatment repeats every 3 weeks for 2 courses.

  Patients receive high-dose cyclophosphamide IV over 1 hour on days 1-3 of week 7. Beginning on day 8, patients receive filgrastim (G-CSF) IV or subcutaneously (SC) daily until day 13. Patients may undergo peripheral blood stem cell (PBSC) collection.

  Patients receive high-dose etoposide IV over 24 hours on days 15-17. Beginning on day 22, patients receive G-CSF IV or SC daily until day 27.

  Patients receive high-dose cyclophosphamide IV over 1 hour on days 29-31. Beginning on day 36, patients receive G-CSF IV or SC daily until day 42. Patients may undergo PBSC collection if not previously performed. Patients who achieve complete response (CR) are removed from study.

  Patients receive high-dose carboplatin IV over 1 hour on days 44-48. Patients undergo PBSC reinfusion on day 52. Beginning on day 55, patients receive G-CSF IV or SC daily until blood counts recover.




• Maintenance chemotherapy: Patients receive maintenance chemotherapy comprising cyclophosphamide, vincristine, and dactinomycin in the same manner as the standard-risk patients.

  Patients with parameningeal disease and those not achieving CR undergo radiotherapy beginning at week 17. Patients achieving CR, unless metastatic disease is resected, undergo radiotherapy beginning on week 15.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Societe Internationale d'Oncologie Pediatrique

Heather McDowell, MD, Protocol chair		Ph: 44-151-293-3679

Children's Cancer and Leukaemia Group

Annabel B.M. Foot, Protocol chair		Ph: 44-117-342-8520

Societe Francaise Oncologie Pediatrique

Christophe Bergeron, Protocol chair		Ph: 33-04-78-782642

Registry Information
Official Title		MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
Trial Start Date		1998-11-01
Registered in ClinicalTrials.gov		NCT00025441
Date Submitted to PDQ		2001-08-16
Information Last Verified		2001-11-02

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