Total Marrow and Total Lymph Node Irradiation, Fludarabine, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Hematological Cancer That Has Not Responded to Treatment
|ClinicalTrials.gov Identifier: NCT00800150|
Recruitment Status : Terminated (Protocol objective could not be met. A new study with amended eligibility criteria will be developed.)
First Posted : December 1, 2008
Last Update Posted : June 8, 2015
RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase I trial is studying the side effects and best dose of total marrow and total lymph node irradiation when given together with fludarabine and melphalan followed by donor stem cell transplant in treating patients with advanced hematological cancer that has not responded to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: fludarabine phosphate Drug: melphalan Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Radiation: intensity-modulated radiation therapy Radiation: tomotherapy Radiation: total marrow irradiation Radiation: total nodal irradiation||Phase 1|
- To determine the maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation (TMLI) using helical tomotherapy in combination with a reduced-intensity preparative regimen comprising fludarabine phosphate and melphalan in patients undergoing allogeneic hematopoietic stem cell transplantation for advanced, relapsed or refractory hematological malignancies.
- To describe the toxicities of escalating doses of TMLI in these patients.
- To describe the frequency of clinical response in patients treated with this regimen.
- To describe the frequency of primary and secondary engraftment failure in patients treated with this regimen.
- To describe the time to neutrophil and platelet engraftment in patients treated with this regimen.
- To describe the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
- To describe the overall survival of patients treated with this regimen.
- To describe the progression-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of intensity-modulated total marrow and lymph node irradiation (TMLI).
- Intensity-modulated radiation therapy: Patients undergo TMLI to skeletal bone/marrow, major lymph node chains, spleen, and liver using helical tomotherapy twice daily on days -6 to -3.
- Reduced-intensity preparative regimen: Patients receive fludarabine phosphate IV on days -6 to -2 and melphalan IV on day -1.
- Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.
After completion of study treatment, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Official Title:||Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and Hematological Malignancies Who Are Not Eligible for Fully Myeloablative Regimen|
|Study Start Date :||November 2008|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
- Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
- Frequency of clinical response
- Frequency of primary and secondary engraftment failure
- Time to neutrophil and platelet engraftment
- Incidence of acute and chronic graft-versus-host disease
- Overall survival
- Progression-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800150
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Joseph Rosenthal, MD||City of Hope Comprehensive Cancer Center|