Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
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| ClinicalTrials.gov Identifier: NCT00003270 |
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Recruitment Status :
Completed
First Posted : April 27, 2004
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients with hematologic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes | Biological: anti-thymocyte globulin Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methylprednisolone Procedure: bone marrow ablation with stem cell support Procedure: umbilical cord blood transplantation Radiation: radiation therapy | Phase 2 |
OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies.
OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell collection prior to transplant regimen, unless the patient has acute leukemia in relapse, aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly for 2 years.
PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this study within 4 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes |
| Actual Study Start Date : | September 4, 1997 |
| Actual Primary Completion Date : | October 16, 2017 |
| Actual Study Completion Date : | October 16, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
Patients eligible to undergo total body irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1. Cord blood is infused on day 0
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Biological: anti-thymocyte globulin
IV Biological: filgrastim IV Drug: busulfan IV Drug: cyclophosphamide IV Drug: cyclosporine IV Drug: methylprednisolone IV Procedure: bone marrow ablation with stem cell support IV Procedure: umbilical cord blood transplantation IV Radiation: radiation therapy High energy X-rays |
- Overall Response Rate [ Time Frame: day +100 after Cord Blood Transplant ]Continuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)
- Progression-free Survival [ Time Frame: 1 year ]time to disease progression or death due to any cause
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| Ages Eligible for Study: | 5 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy Acute lymphocytic leukemia (ALL): In second or later remission In first remission with poor prognostic features (Philadelphia chromosome positive) Acute myeloid leukemia (AML): In second or later remission In first remission with poor prognostic features, e.g., Arising from myelodysplastic syndrome Cytogenetics with -5, -7, +8, 11q23 abnormalities Complex cytogenetics AML or ALL refractory to induction or in relapse Myelodysplastic syndrome Chronic myelogenous leukemia Severe aplastic anemia or Fanconi's anemia Relapsed Hodgkin's disease Relapsed non-Hodgkin's lymphoma Multiple myeloma No suitable family donor matched for 5 or 6 HLA antigens (A, B, DR) No suitable unrelated donor matched for 6 HLA antigens Cord blood donor available matched for 4-6 out of 6 HLA antigens
PATIENT CHARACTERISTICS: Age: 5 to 50 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times normal Alkaline phosphatase less than 3 times normal SGOT less than 3 times normal Renal: Creatinine less than 2 times normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: MUGA with ejection fraction at least 50% Pulmonary: DLCO and spirometry at least 60% OR Exercise VO2 max/kg at least 15 mL/min/kg Other: HIV antibody negative Hepatitis B surface antigen negative No active bacterial, viral, or fungal infection
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed If following limits have not been exceeded, patient may receive total body irradiation: No prior radiation to one entire kidney Whole liver received no greater than 1000 cGy No prior whole abdomen radiotherapy Small bowel received no greater than 3000 cGy Heart received no greater than 1800 cGy No prior whole lung radiotherapy CNS received less than 30 cGy (whole brain or any portion of the spine) 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): NCT00003270
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Study Chair: | Barbara Jean Bambach, MD | Roswell Park Cancer Institute |
Documents provided by Roswell Park Cancer Institute:
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00003270 |
| Other Study ID Numbers: |
DS 97-26 DS 97-26 |
| First Posted: | April 27, 2004 Key Record Dates |
| Results First Posted: | December 13, 2019 |
| Last Update Posted: | December 13, 2019 |
| Last Verified: | November 2019 |
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recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma Burkitt lymphoma refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous 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 myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent/refractory childhood Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
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Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Myelodysplastic Syndromes Graft vs Host Disease 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 Cyclosporine Methylprednisolone Cyclophosphamide Busulfan Cyclosporins |