Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
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Purpose
RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation.
PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Biological: Filgrastim Drug: Cyclosporine Drug: Decitabine Procedure: Allogeneic Bone Marrow Transplantation Procedure: Peripheral Blood Stem Cell Transplantation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation |
- Maximum Tolerated Dose (MTD) Decitabine [ Time Frame: Weekly for 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | August 1995 |
| Study Completion Date: | March 2002 |
| Primary Completion Date: | March 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Decitabine + Stem Cell Transplantation |
Biological: Filgrastim
Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection then daily starting 1 day after PBSC infusion until blood counts recover.
Other Names:
Drug: Cyclosporine
IV daily on day -2, then orally once dose is tolerable, dose may be escalated.
Other Names:
Drug: Decitabine
IV for 6 hours every 12 hr for 5 days.
Other Name: Dacogen
Procedure: Allogeneic Bone Marrow Transplantation
Stem cell infusion on Day 0.
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation
Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine.
Other Name: PBSC
|
Detailed Description:
OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with relapse post allogenic bone marrow transplant. II. Determine the toxicity of decitabine combined with filgrastim (G-CSF) primed allogeneic peripheral blood stem cells in patients who relapsed within 1 year after allogeneic bone marrow transplantation. III. Determine the effectiveness in reinducing remission in these patients.
OUTLINE: Patients receive decitabine IV for 6 hours every 12 hr for 5 days. Peripheral blood stem cells (PBSC) are administered 5 days after last dose of decitabine. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to first PBSC collection. If insufficient number of cells are collected, bone marrow can be harvested for supplementation. Donor cells should be collected prior to decitabine infusion. Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover. For GVHD prophylaxis, patients receive cyclosporine IV daily on day -2, then orally once dose is tolerable. Dose of decitabine is escalated in cohorts of 3-6 patients. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then that dose is declared the maximum tolerated dose. Patients are followed weekly. If none of the first 5 patients survive in remission for more than 100 days, the study will be terminated.
PROJECTED ACCRUAL: At least 15 patients will be accrued for this study over 2 years.
Eligibility| Ages Eligible for Study: | up to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Acute leukemia, myelodysplastic syndromes or chronic myelogenous leukemia (CML) in accelerated phase or blast crisis and relapsed within 1 year after allogeneic bone marrow transplantation Must not be candidates for second course of high dose chemoradiotherapy
PATIENT CHARACTERISTICS: Age: 60 and under Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: Greater than 40% ejection fraction per MUGA scan or ECHO Other: Not pregnant No serious intercurrent illness No active CNS disease Must be ineligible for protocols of higher priority No active acute graft vs host disease (GVHD) greater than grade 2 or extensive chronic GVHD No active uncontrolled infection Original marrow donor must undergo filgrastim primed peripheral blood stem cell collection
PRIOR CONCURRENT THERAPY: See Disease Characteristics
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Sergio Giralt, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00002832 History of Changes |
| Other Study ID Numbers: | DM94-077, P30CA016672, MDA-DM-94077, NCI-G96-1000, CDR0000065034 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
Decitabine Dacogen Filgrastim G-CSF Neupogen Cyclosporine Sandimmune CYA Cyclosporin A Peripheral blood stem cells |
PBSC Allogeneic bone marrow transplantation recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia previously treated myelodysplastic syndromes childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cyclosporins Cyclosporine Decitabine Lenograstim |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on June 17, 2013