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

Phase 1

Terminated

• Conditions: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic/Myeloproliferative Neoplasms; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

• Registration Number: NCT00800150
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-27
• Study First Submitted QC: 2008-11-27
• Study First Posted: 2008-12-01
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation using helical tomotherapy
Toxicity

Secondary Outcome Measures

Name	Time	Method
Time to neutrophil and platelet engraftment
Incidence of acute and chronic graft-versus-host disease
Progression-free survival
Frequency of clinical response
Frequency of primary and secondary engraftment failure
Overall survival

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States