Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00005092|
Recruitment Status : Completed
First Posted : April 23, 2004
Last Update Posted : July 31, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Drug: Cyclophosphamide Drug: Psoralen Drug: Thiotepa Procedure: Allogeneic bone marrow transplantation Procedure: In vitro-treated peripheral blood stem cell transplantation (PBSCT) Radiation: Radiation Therapy (RT)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||August 2002|
Experimental: Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
IV over 2 hours on days 2 and 3
Other Names:Drug: Psoralen
Psoralen treated T-cell allogeneic transplant on day 9
Other Names:Drug: Thiotepa
IV over 2 hours on day 1Procedure: Allogeneic bone marrow transplantation
Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9Procedure: In vitro-treated peripheral blood stem cell transplantation (PBSCT)
Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9
Other Name: PBSCTRadiation: Radiation Therapy (RT)
Whole body radiotherapy on days 5-8.
Other Name: Radiotherapy
- Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005092
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Missouri|
|Washington University Barnard Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||James Gajewski, MD||M.D. Anderson Cancer Center|