Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04994132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2021-07-09
Brief Title:
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Randomized Phase 3 Trial of Vinorelbine Dactinomycin and Cyclophosphamide VINO-AC Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide VINO-CPO vs Vincristine Dactinomycin and Cyclophosphamide VAC Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma HR-RMS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial compares the safety and effect of adding vinorelbine to vincristine dactinomycin and cyclophosphamide VAC for the treatment of patients with high risk rhabdomyosarcoma RMS High risk refers to cancer that is likely to recur come back after treatment or spread to other parts of the body This study will also examine if adding maintenance therapy after VAC therapy with or without vinorelbine will help get rid of the cancer andor lower the chance that the cancer comes back Vinorelbine and vincristine are in a class of medications called vinca alkaloids They work by stopping cancer cells from growing and dividing and may kill them Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy It works by damaging the cells deoxyribonucleic acid DNA and may kill cancer cells Cyclophosphamide is in a class of medications called alkylating agents It works by damaging the cells DNA and may kill cancer cells It may also lower the bodys immune response Vinorelbine vincristine dactinomycin and cyclophosphamide are chemotherapy medications that work in different ways to stop the growth of cancer cells either by killing the cells by stopping them from dividing or by stopping them from spreading This trial may have the potential to eliminate rhabdomyosarcoma for a long time or for the rest of patients life
Detailed Description:
PRIMARY OBJECTIVE
I To compare event-free survival EFS of patients with high-risk rhabdomyosarcoma HR-RMS treated with vinorelbine dactinomycin and cyclophosphamide VINO-AC followed by 24 weeks of vinorelbine and oral cyclophosphamide VINO-CPO maintenance therapy to that of patients treated with vincristine dactinomycin and cyclophosphamide VAC followed by 24 weeks of VINO-CPO maintenance therapy
SECONDARY OBJECTIVES
I To assess the safety and feasibility of administering VINO-AC in newly diagnosed patients with HR-RMS
II To describe the toxicity experience of patients with HR-RMS treated with VINO-AC compared to VAC
III To compare overall survival OS of patients with HR-RMS treated with VINO AC followed by 24 weeks of VINO-CPO maintenance therapy to that of patients treated with VAC followed by 24 weeks of VINO-CPO maintenance therapy
IV To compare objective radiologic response rates at week 12 between patients with HR-RMS treated with VINO-AC to those treated with VAC
V To determine whether the addition of 24 weeks of VINO-CPO maintenance therapy improves EFS in patients with HR-RMS when compared to historical controls
EXPLORATORY OBJECTIVE
I To collect serial blood samples and tumor tissue for banking at baseline during treatment at the end of therapy and at the time of progression for future tumor and liquid biopsy studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive vincristine sulfate intravenously IV on days 1 8 and 15 of cycles 1-4 7 8 11 and 12 and day 1 of cycles 5 6 9 10 13 and 14 Patients also receive dactinomycin IV over 1-15 minutes or IV push IVP over 1-5 minutes on day 1 of cycles 1-5 8-10 and 11-14 and cyclophosphamide IV over 60 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy on weeks 13 and 40
ARM B Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8 vincristine sulfate IV on day 15 dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5 and 8-14 and cyclophosphamide IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy on weeks 13 and 40
MAINTENANCE All patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 8 and 15 and cyclophosphamide orally PO on days 1-28 Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
Patients in both arms undergo computed tomography CT magnetic resonance imaging MRI positron emission tomography PET x-ray imaging andor bone scan as well as blood sample collection throughout the trial Patients may also undergo bone marrow aspiration andor biopsy as clinically indicated
After completion of study treatment patients are followed up every 3 months for year 1 every 4 months for years 2-3 and every 6 months for years 4-5
I To compare event-free survival EFS of patients with high-risk rhabdomyosarcoma HR-RMS treated with vinorelbine dactinomycin and cyclophosphamide VINO-AC followed by 24 weeks of vinorelbine and oral cyclophosphamide VINO-CPO maintenance therapy to that of patients treated with vincristine dactinomycin and cyclophosphamide VAC followed by 24 weeks of VINO-CPO maintenance therapy
SECONDARY OBJECTIVES
I To assess the safety and feasibility of administering VINO-AC in newly diagnosed patients with HR-RMS
II To describe the toxicity experience of patients with HR-RMS treated with VINO-AC compared to VAC
III To compare overall survival OS of patients with HR-RMS treated with VINO AC followed by 24 weeks of VINO-CPO maintenance therapy to that of patients treated with VAC followed by 24 weeks of VINO-CPO maintenance therapy
IV To compare objective radiologic response rates at week 12 between patients with HR-RMS treated with VINO-AC to those treated with VAC
V To determine whether the addition of 24 weeks of VINO-CPO maintenance therapy improves EFS in patients with HR-RMS when compared to historical controls
EXPLORATORY OBJECTIVE
I To collect serial blood samples and tumor tissue for banking at baseline during treatment at the end of therapy and at the time of progression for future tumor and liquid biopsy studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive vincristine sulfate intravenously IV on days 1 8 and 15 of cycles 1-4 7 8 11 and 12 and day 1 of cycles 5 6 9 10 13 and 14 Patients also receive dactinomycin IV over 1-15 minutes or IV push IVP over 1-5 minutes on day 1 of cycles 1-5 8-10 and 11-14 and cyclophosphamide IV over 60 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy on weeks 13 and 40
ARM B Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8 vincristine sulfate IV on day 15 dactinomycin IV over 1-15 minutes or IVP over 1-5 minutes on day 1 of cycles 1-5 and 8-14 and cyclophosphamide IV over 60 minutes on day 1 Treatment repeats every 21 days for up to 14 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo radiation therapy on weeks 13 and 40
MAINTENANCE All patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 8 and 15 and cyclophosphamide orally PO on days 1-28 Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
Patients in both arms undergo computed tomography CT magnetic resonance imaging MRI positron emission tomography PET x-ray imaging andor bone scan as well as blood sample collection throughout the trial Patients may also undergo bone marrow aspiration andor biopsy as clinically indicated
After completion of study treatment patients are followed up every 3 months for year 1 every 4 months for years 2-3 and every 6 months for years 4-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-06711 | REGISTRY | None | None |
| ARST2031 | OTHER | None | None |
| ARST2031 | OTHER | None | None |
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |