Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any - 49
Updated:10/28/2018
Start Date:May 28, 1999
End Date:August 28, 2002

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A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation

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.

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.

DISEASE CHARACTERISTICS: Hematologic malignancy, including acute myeloid or lymphoid
leukemia of any FAB subtype, not in remission with chemotherapy or requiring bone marrow
transplant OR Chronic myeloid leukemia, advanced beyond first chronic phase OR
Myelodysplasia, including secondary to prior chemotherapy, with: Granulocyte count less
than 500/mm3 OR Platelet count less than 50,000/mm3 OR High risk cytogenetic abnormalities
such as +8, -7, -5, or 11q23 OR Intermediate or high grade lymphoma without response to
initial therapy or in relapse OR Multiple myeloma without response to initial therapy or in
relapse OR Stage IV low grade lymphoma or chronic lymphocytic leukemia not achieving
remission with 2 regimens No aplastic anemia Related haploidentical donor (1-3 HLA-A, B,
and/or DR mismatch) for collection of stem cells and whole blood T-cells required

PATIENT CHARACTERISTICS: Age: 6 months to 49 years Performance status: ECOG 0-2 Life
expectancy: Greater than 12 weeks Hematopoietic: See Disease Characteristics Hepatic:
Bilirubin less than 1.5 mg/dL SGPT less than 3 times upper limit of normal Renal:
Creatinine less than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least
45% No symptoms or active treatment of left ventricular failure Pulmonary: Corrected DLCO
at least 50% Other: No acute viral, bacterial, or fungal infection No prior transfusion
associated graft versus host disease No other medical condition that would preclude study
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy or
interferon alfa and recovered No prior autologous or allogeneic progenitor cell transplant
Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and
recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior
radiotherapy and recovered Surgery: Not specified
We found this trial at
3
sites
Saint Louis, Missouri 63110
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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