Ovarian CancerPhase 2NCT00025441
Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
A Phase 2 study testing dactinomycin, filgrastim and carboplatin in people with Ovarian Cancer and Sarcoma, run by Societe Internationale d'Oncologie Pediatrique at 22 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Ovarian Cancer, Sarcoma, Small Intestine Cancer
- What is being tested?
- dactinomycin, filgrastim and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 22 sitesin 3 countries
- Study dates
- Nov 1998to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United Kingdom20 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, BT12 6BE
Birmingham Children's Hospital
Birmingham, England, B4 6NH
Bristol Royal Hospital for Children
Bristol, England, BS2 8BJ
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Royal Hospital for Sick Children
Edinburgh, Scotland
Royal Hospital for Sick Children
Glasgow, Scotland, G3 8SJ
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, L12 2AP
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Leeds Cancer Centre at St. James's University Hospital
London, England, W6 8RF
Great Ormond Street Hospital for Children NHS Trust
London, England, WC1N 3JH
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, WIT 3AA
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, M27 4HA
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, NE7 7DN
Queen's Medical Centre
Nottingham, England, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, S10 2TH
Southampton General Hospital
Southampton, England, SO16 6YD
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, SM2 5PT
About this study
Official title: MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
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.
Read the detailed description
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
- Ovarian Cancer, Sarcoma, Small Intestine Cancer
- Being tested
- dactinomycin, filgrastim, carboplatin, cyclophosphamide, doxorubicin hydrochloride
- Keywords
- 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
- Medical subject headings
- Ovarian Neoplasms, Sarcoma, Chondrosarcoma, Neuroectodermal Tumors, Primitive, Peripheral, Fibrosarcoma, Hemangiopericytoma, Malignant, Liposarcoma, Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dactinomycinBiological
filgrastimBiological
carboplatinDrug
cyclophosphamideDrug
epirubicin hydrochlorideDrug
etoposideDrug
ifosfamideDrug
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 1998
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Societe Internationale d'Oncologie Pediatrique
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer and Leukaemia Group, Societe Francaise Oncologie Pediatrique
- Investigators
- Heather P. McDowell, MD, Study chair, Royal Liverpool Children's Hospital, Alder HeyAnnabel B.M. Foot, Study chair, Bristol Royal Hospital for ChildrenChristophe Bergeron, Study chair, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025441
- Sponsor's protocol ID
- CDR0000068961
- Other IDs
- SIOP-MMT-98, SFOP-SIOP-MMT-98, CCLG-SIOP-MMT-98, EU-20126, STS-1998
- Status last verified
- Nov 2001
- First submitted
- 11 Oct 2001
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
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.
PubMed 20338746
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MMT 98 Study For Metastatic Disease Rhabdomyosarcoma And Other Malignant Soft Tissue Sarcoma Of Childhood
- ClinicalTrials.gov ID
- NCT00025441
- Acronym / sponsor ID
- CDR0000068961
- Conditions
- Ovarian Cancer, Sarcoma, Small Intestine Cancer
- Keywords
- chondrosarcoma, small intestine leiomyosarcoma, fibrosarcomatous osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, pleomorphic childhood rhabdomyosarcoma, mixed childhood rhabdomyosarcoma, embryonal-botryoid childhood rhabdomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Societe Internationale d'Oncologie PediatriqueUniversity, hospital or other
- Collaborators
- Children's Cancer and Leukaemia Group, Societe Francaise Oncologie Pediatrique
- Study start
- Nov 1998
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dactinomycin | Biological | – |
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| vincristine sulfate | Drug | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Results publication: PubMed 20338746McDowell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather P. McDowell, MD study chair
Royal Liverpool Children's Hospital, Alder Hey
Annabel B.M. Foot study chair
Bristol Royal Hospital for Children
Christophe Bergeron study chair
Centre Leon Berard
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dactinomycin, filgrastim and carboplatin in people with Ovarian Cancer and Sarcoma, run by Societe Internationale d'Oncologie Pediatrique at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, France, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00025441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.