Study on Chemotherapy With or Without Temsirolimus for Treating Patients With Intermediate Risk Rhabdomyosarcoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02567435
This clinical trial is exploring whether adding the drug temsirolimus to standard chemotherapy can improve treatment outcomes for patients with intermediate-risk rhabdomyosarcoma, a type of cancer that forms in soft tissues like muscles.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if adding temsirolimus to a combination of chemotherapy drugs can better control rhabdomyosarcoma, a cancer that affects soft tissues such as muscles, in patients who have an intermediate risk of the cancer returning after treatment. The chemotherapy drugs work by killing cancer cells or stopping them from growing and spreading. Temsirolimus may help by blocking certain enzymes needed for cancer cell growth. Researchers want to find out if this combination is more effective than chemotherapy alone.
Description
The study is divided into different phases to compare the effectiveness of treatments. In the first phase, researchers tested different doses of temsirolimus to find a safe level. Now, in the main phase, patients are randomly assigned to one of two treatment groups. One group receives standard chemotherapy, while the other group receives chemotherapy plus temsirolimus. Both groups also receive surgery and radiation therapy as part of their treatment.
The main goal is to see if the combination of chemotherapy and temsirolimus can help patients live longer without the cancer coming back. Researchers will also look at overall survival rates and other factors, such as genetic markers and responses to treatment, to understand how different patients respond to the therapies.
Patients in the study will receive various chemotherapy drugs at specific times, along with radiation therapy. After completing the treatment, patients will be monitored regularly to check for any signs of cancer returning and to assess their overall health.
Eligibility Criteria
Inclusion Criteria
- Patients must be 40 years old or younger at the time of enrollment.
- Must have a new diagnosis of rhabdomyosarcoma, except for adult-type pleomorphic subtype.
- Must have enough tissue available for required biological studies.
- Must have a performance status score of at least 50, indicating they are able to carry out daily activities.
- Must have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 750/uL.
- Platelet count of at least 75,000/uL.
- Creatinine clearance or GFR of at least 70 mL/min/1.73 m² or specific serum creatinine levels based on age and gender.
- Total bilirubin must be within 1.5 times the normal limit for age.
- Must sign a written informed consent form.
- Must meet all institutional, FDA, and NCI requirements for human studies.
Exclusion Criteria
- Patients who have previously received temsirolimus or similar drugs.
- Patients who have received chemotherapy or radiation therapy before enrolling in this study.
- Patients with uncontrolled high blood sugar or high cholesterol levels.
- Sexually active patients who are not using effective birth control during the study and for at least 3 months after treatment.
- Pregnant women are not eligible due to potential risks to the fetus. A pregnancy test is required for women of childbearing potential before starting the study.
- Breastfeeding women who plan to continue breastfeeding are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.