Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
- Conditions
- LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes
- Interventions
- Procedure: Allogeneic bone marrow transplantationProcedure: In vitro-treated peripheral blood stem cell transplantation (PBSCT)Radiation: Radiation Therapy (RT)
- Registration Number
- NCT00005092
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.
- Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of T-cells photochemically treated with psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with hematologic malignancies or bone marrow failure myelodysplastic syndrome. II. Assess the toxicity of this treatment in these patients. III. Evaluate this regimen in terms of prevention of graft versus host disease and control of malignancy in these patients.
OUTLINE: This is a dose escalation, multicenter study of T-cells photochemically treated with psoralen and ultraviolet A. Patients receive thiotepa IV over 2 hours on day 1, cyclophosphamide IV over 2 hours on days 2 and 3, and whole body radiotherapy on days 5-8. Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9. Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients are followed for 100 days.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemo, RT + PSCT Cyclophosphamide Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation Chemo, RT + PSCT Allogeneic bone marrow transplantation Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation Chemo, RT + PSCT Radiation Therapy (RT) Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation Chemo, RT + PSCT Thiotepa Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation Chemo, RT + PSCT In vitro-treated peripheral blood stem cell transplantation (PBSCT) Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation Chemo, RT + PSCT Psoralen Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A 100 days MTD defined as dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients followed for 100 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, United States