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	Treatment or Intervention	Phase
Leukemia Lymphoma Multiple Myeloma Eye Cancer	Drug: cyclophosphamide  Drug: psoralen  Drug: thiotepa	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  up to  49 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Illinois
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Missouri
      Washington University Barnard Cancer Center, Saint Louis,  Missouri,  63110,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

James Gajewski,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067734; MDA-DM-98283; NCI-G00-1742
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005092
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08