Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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| ClinicalTrials.gov Identifier: NCT00005092 |
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Recruitment Status :
Completed
First Posted : April 23, 2004
Last Update Posted : October 26, 2018
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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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation |
| Actual Study Start Date : | May 28, 1999 |
| Actual Primary Completion Date : | August 28, 2002 |
| Actual Study Completion Date : | August 28, 2002 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
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Drug: Cyclophosphamide
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 1 Procedure: Allogeneic bone marrow transplantation Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9 Procedure: 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: PBSCT Radiation: 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.
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| Ages Eligible for Study: | up to 49 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00005092 |
| Other Study ID Numbers: |
DM98-283 P30CA016672 ( U.S. NIH Grant/Contract ) MDA-DM-98283 ( Other Identifier: UT MD Anderson Cancer Center ) NCI-G00-1742 CDR0000067734 ( Registry Identifier: NCI PDQ ) |
| First Posted: | April 23, 2004 Key Record Dates |
| Last Update Posted: | October 26, 2018 |
| Last Verified: | October 2018 |
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stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma stage III multiple myeloma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia |
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia childhood diffuse large cell lymphoma childhood immunoblastic large cell lymphoma chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia adult acute monoblastic leukemia and acute monocytic leukemia (M5) childhood acute monoblastic leukemia and acute monocytic leukemia (M5) T-cell large granular lymphocyte leukemia B-cell chronic lymphocytic leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Myelodysplastic Syndromes Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Cyclophosphamide Thiotepa Methoxsalen Furocoumarins Immunosuppressive Agents Immunologic Factors |