Reduced Intensity BMT for Solid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the trial coordinators or your doctor.
Is the reduced intensity BMT treatment generally safe for humans?
How is the drug combination of Cyclophosphamide and Melphalan unique for treating solid cancer?
The combination of Cyclophosphamide and Melphalan for solid cancer is unique because it uses a reduced intensity approach, which may offer a less aggressive treatment option compared to traditional high-dose regimens. This approach is novel as it potentially reduces side effects while still aiming to be effective, especially since there are no standard treatments for solid cancers using this specific combination.13678
What data supports the effectiveness of the drug Melphalan in the treatment of solid cancer?
Who Is on the Research Team?
Heather Symons, MD, MHS
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for patients with high-risk solid tumors who have a low chance of survival and haven't responded well to standard treatments. They need normal kidney function, decent heart function, and good overall health status. Participants must have a related donor who's partially genetically matched for bone marrow donation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment Evaluation
Documentation of detailed history, physical examination, and standard evaluation of cardiac, pulmonary, liver, and renal function
Preparative Regimen
Administration of Fludarabine, Melphalan, and Total Body Irradiation before bone marrow transplantation
Bone Marrow Transplantation
Bone marrow harvested and infused, followed by post-transplantation cyclophosphamide and immunosuppression regimen
Follow-up
Participants are monitored for safety, effectiveness, and incidence of GVHD and other complications
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- Low Dose Total Body Irradiation
- Melphalan
- Tacrolimus
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
National Cancer Institute (NCI)
Collaborator