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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children with metastatic rhabdomyosarcoma or other malignant mesenchymal tumors.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* 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.
* Determine the role of low-intensity maintenance chemotherapy after intensive conventional chemotherapy in standard-risk children.
* Determine the value of a therapeutic window in high-risk children.
* Determine the role of sequential high-dose chemotherapy with peripheral blood stem cell transplantation in achieving complete response in high-risk children.
* Determine the complete response, overall survival, and event-free survival in high-risk children.

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.

PROJECTED ACCRUAL: 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer Sarcoma Small Intestine Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chondrosarcoma small intestine leiomyosarcoma fibrosarcomatous osteosarcoma embryonal childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma pleomorphic childhood rhabdomyosarcoma mixed childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma metastatic childhood soft tissue sarcoma extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood fibrosarcoma childhood synovial sarcoma childhood malignant hemangiopericytoma childhood liposarcoma childhood alveolar soft-part sarcoma childhood leiomyosarcoma childhood angiosarcoma childhood epithelioid sarcoma childhood malignant mesenchymoma stage IV uterine sarcoma uterine leiomyosarcoma ovarian sarcoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dactinomycin

Intervention Type BIOLOGICAL

filgrastim

Intervention Type BIOLOGICAL

carboplatin

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

epirubicin hydrochloride

Intervention Type DRUG

etoposide

Intervention Type DRUG

ifosfamide

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

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

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather P. McDowell, MD

Role: STUDY_CHAIR

Royal Liverpool Children's Hospital, Alder Hey

Annabel B.M. Foot

Role: STUDY_CHAIR

Bristol Royal Hospital for Children

Christophe Bergeron

Role: STUDY_CHAIR

Centre Leon Berard

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Leon Berard

Lyon, , France

Site Status

Our Lady's Hospital for Sick Children

Crumlin, , Ireland

Site Status

Birmingham Children's Hospital

Birmingham, England, United Kingdom

Site Status

Bristol Royal Hospital for Children

Bristol, England, United Kingdom

Site Status

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Site Status

Leicester Royal Infirmary

Leicester, England, United Kingdom

Site Status

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, United Kingdom

Site Status

Saint Bartholomew's Hospital

London, England, United Kingdom

Site Status

Leeds Cancer Centre at St. James's University Hospital

London, England, United Kingdom

Site Status

Great Ormond Street Hospital for Children NHS Trust

London, England, United Kingdom

Site Status

Meyerstein Institute of Oncology at University College of London Hospitals

London, England, United Kingdom

Site Status

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, United Kingdom

Site Status

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, United Kingdom

Site Status

Queen's Medical Centre

Nottingham, England, United Kingdom

Site Status

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Site Status

Children's Hospital - Sheffield

Sheffield, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, United Kingdom

Site Status

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Site Status

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Site Status

Royal Hospital for Sick Children

Glasgow, Scotland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Ireland United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

McDowell HP, Foot AB, Ellershaw C, Machin D, Giraud C, Bergeron C. Outcomes in paediatric metastatic rhabdomyosarcoma: results of The International Society of Paediatric Oncology (SIOP) study MMT-98. Eur J Cancer. 2010 Jun;46(9):1588-95. doi: 10.1016/j.ejca.2010.02.051. Epub 2010 Mar 24.

Reference Type RESULT

PMID: 20338746 (View on PubMed)