Study Comparing Early Use of Vinorelbine and Maintenance Therapy for High-Risk Rhabdomyosarcoma
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT04994132
This clinical trial is testing whether adding the drug vinorelbine to a standard chemotherapy treatment can help control high-risk rhabdomyosarcoma, a type of cancer that often returns or spreads. The study also examines if continuing treatment after initial therapy can further reduce the chance of the cancer coming back.
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Program Overview
This study is exploring whether adding vinorelbine to the standard chemotherapy drugs vincristine, dactinomycin, and cyclophosphamide can improve treatment outcomes for patients with high-risk rhabdomyosarcoma (RMS). High-risk means the cancer is likely to return or spread after treatment. The study will also look at whether continuing treatment with vinorelbine and cyclophosphamide after the initial therapy can help eliminate the cancer or lower the chance of it coming back. These drugs work by stopping cancer cells from growing and dividing, potentially killing them. The trial aims to find out if this approach can keep rhabdomyosarcoma away for a long time or even permanently.
Description
The main goal of this study is to compare how well patients with high-risk rhabdomyosarcoma (HR-RMS) do when treated with a combination of vinorelbine, dactinomycin, and cyclophosphamide (VINO-AC), followed by maintenance therapy with vinorelbine and oral cyclophosphamide (VINO-CPO), versus those treated with vincristine, dactinomycin, and cyclophosphamide (VAC) followed by the same maintenance therapy.
Secondary goals include assessing the safety of VINO-AC in newly diagnosed patients, comparing the side effects of VINO-AC and VAC, and evaluating overall survival rates. The study will also look at how well the cancer responds to treatment by week 12 and whether the maintenance therapy improves outcomes compared to past treatments. Additionally, researchers will study the relationship between certain genetic markers and treatment success.
Participants will be randomly assigned to one of two groups. In Group A, patients receive vincristine, dactinomycin, and cyclophosphamide in cycles, along with radiation therapy at specific times. In Group B, patients receive vinorelbine, vincristine, dactinomycin, and cyclophosphamide in cycles, also with radiation therapy. After the initial treatment, all patients receive maintenance therapy with vinorelbine and oral cyclophosphamide.
Throughout the trial, patients will undergo various scans and tests, including CT, MRI, PET, x-rays, and blood tests. Bone marrow tests may also be done if needed. After completing the study treatment, patients will have follow-up visits every few months for up to five years.
Eligibility Criteria
Inclusion Criteria
- Must be 50 years old or younger.
- Newly diagnosed with rhabdomyosarcoma (RMS), except for adult-type pleomorphic RMS.
- Specific types of RMS, such as embryonal RMS (ERMS) and alveolar RMS (ARMS), are included based on stage, group, and age.
- Bone marrow involvement must be confirmed by specific tests.
- Adequate kidney function as shown by specific tests.
- Total bilirubin levels within acceptable limits, unless affected by tumor-related bile duct blockage.
- Must provide informed consent.
- Must meet all institutional, FDA, and NCI requirements for human studies.
Exclusion Criteria
- Uncontrolled infections.
- RMS as a second cancer or previous cancers treated with chemotherapy or radiation (surgery alone is allowed).
- Central nervous system involvement of RMS, such as cancer cells in the spinal fluid or brain metastasis.
- Previous chemotherapy or radiation for RMS, except emergency radiation therapy.
- Use of certain drugs that affect the study medications within 7 days before enrollment.
- Pregnant or breastfeeding women.
- Sexually active patients not using effective contraception during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
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