Study on Irinotecan and Carboplatin as Initial Treatment for Newly Diagnosed Intermediate or High-Risk Rhabdomyosarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT00077285
This clinical trial is testing how well the combination of chemotherapy drugs irinotecan and carboplatin works as the first treatment for patients with newly diagnosed intermediate or high-risk rhabdomyosarcoma, a type of cancer.
Patient Parameters
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Program Overview
The purpose of this study is to see if using the chemotherapy drugs irinotecan and carboplatin together as the first treatment can effectively treat patients with newly diagnosed intermediate or high-risk rhabdomyosarcoma. These drugs work by stopping cancer cells from growing and dividing, which may help shrink the tumors.
Description
The study aims to find out how well the combination of irinotecan and carboplatin works in treating patients with newly diagnosed intermediate or high-risk rhabdomyosarcoma. It will also look at the side effects of this treatment when combined with radiotherapy and how safe and feasible it is to use this treatment plan. The study will also evaluate how well the treatment controls the cancer when combined with a specific type of radiotherapy.
The study is divided into several courses of treatment:
- Courses 1 and 2: Patients receive carboplatin and irinotecan over several days, repeated every 21 days for two cycles.
- Courses 3-5: Patients receive a combination of vincristine, dexrazoxane, doxorubicin, cyclophosphamide, and a growth factor to help blood counts recover, repeated every 21 days for three cycles.
- Courses 6 and 7: Patients receive vincristine, carboplatin, irinotecan, and a growth factor, repeated every 21 days for two cycles.
- Courses 8 and 9: Patients receive vincristine, etoposide, ifosfamide, and a growth factor, repeated every 21 days for two cycles.
- Course 10: Patients receive vincristine, dexrazoxane, doxorubicin, cyclophosphamide, and a growth factor.
- Courses 11 and 12: Patients receive etoposide, ifosfamide, and a growth factor, repeated every 21 days for two cycles.
Patients with high-risk disease may receive additional maintenance therapy with irinotecan.
Patients will be monitored regularly after treatment to check for any recurrence of the disease. Follow-up visits will occur monthly for the first year, every three months for the second year, every six months for the third year, and annually thereafter.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma, confirmed by a pathologist.
- Intermediate or high-risk features, including:
- Stage 4 tumors with distant metastases.
- Non-metastatic undifferentiated sarcoma or alveolar rhabdomyosarcoma.
- Patients under 1 year old with non-metastatic embryonal rhabdomyosarcoma.
- Patients 1 year or older with specific stage and group criteria.
- Age 50 years or younger at diagnosis.
- Biopsy or surgery within 42 days before starting treatment.
- Normal kidney, liver, heart, and blood function.
- No need for measurable disease.
- Willing to have a central venous catheter.
- Sexually active patients must use effective contraception.
- Ability to provide informed consent.
Exclusion Criteria
- Previous chemotherapy or radiotherapy, except for emergency situations.
- Pregnant or breastfeeding women due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
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