Radiolabeled Monoclonal Antibody + Chemotherapy Before Stem Cell Transplant for Hodgkin Lymphoma
Trial Summary
What is the purpose of this trial?
This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells
Research Team
Eileen Smith
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults with Hodgkin lymphoma that didn't respond to initial treatment or came back after therapy. Participants must have acceptable organ function, not be pregnant or breastfeeding, agree to use birth control, and have collected enough stem cells for transplant. They should not have had certain previous treatments like high-dose chemo with stem cell transplant or radiation to critical organs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dosimetry Study
Patients receive basiliximab IV and indium In 111 basiliximab IV on day -21 and undergo imaging scans to determine biodistribution
Treatment
Patients receive basiliximab IV and yttrium Y 90 basiliximab IV on day -14, followed by BEAM chemotherapy and autologous hematopoietic progenitor cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Basiliximab
- Carmustine
- Cytarabine
- Etoposide
- Melphalan
- Radiolabeled Monoclonal Antibody Therapy
- Yttrium Y 90-labeled basiliximab
Carmustine is already approved in United States, European Union, Canada for the following indications:
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
- Brain tumors
- Multiple myeloma
- Hodgkin's disease
- Non-Hodgkin's lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator