Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00014469
First received: April 10, 2001
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms |
Drug: busulfan Drug: melphalan Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of IV Busulfan (Busulfex) and Melphalan as a Preparatory Regimen Prior to Allogeneic Bone Marrow Transplantation for the Treatment of Advanced and High Risk Hematologic Malignancies |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Bone Marrow Transplantation
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
Drug Information available for:
Busulfan
Methotrexate
Melphalan
Melphalan hydrochloride
Methotrexate sodium
Tacrolimus
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
| Study Start Date: | December 2000 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the antileukemic potential of busulfan and melphalan prior to allogeneic bone marrow transplantation in patients with advanced or high-risk hematologic malignancy.
- Determine the incidence of transplantation-related morbidity and mortality in patients treated with this regimen.
- Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
OUTLINE: Patients receive cytoreductive chemotherapy comprising busulfan IV over 2 hours every 6 hours for a total of 16 doses on days -8 to -5 and melphalan IV over 30 minutes on days -4 to -2. Patients undergo T-cell replete allogeneic bone marrow transplantation on day 0. For graft-versus-host disease prophylaxis, patients receive tacrolimus IV continuously or every 12 hours beginning on day -1 and continuing for 50 days to 6 months followed by a taper. Once oral medications are tolerated, patients switch to oral tacrolimus every 12 hours. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed weekly through day 100, every 6 weeks for 3 months, every 3 months for 1 year, and then every 3-6 months for 6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
- Infant leukemia
- Acute lymphoblastic leukemia in 3rd or greater remission or relapse
- Undifferentiated or biphenotypic leukemia in 2nd or greater remission or relapse
- Juvenile chronic myelogenous leukemia (CML)
- Acute myelogenous leukemia (AML) in 3rd or greater remission or relapse
- Primary advanced myelodysplastic syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts
- Therapy-related MDS of any stage or AML
- CML in 2nd or greater chronic phase, accelerated, or blastic phase
- Acute leukemia, CML, or MDS but unable to tolerate total body irradiation (TBI) due to potential neurotoxicity (prior TBI, prior local radiotherapy,or under 2 years of age)
- No active CNS disease
- Related or unrelated bone marrow donor matched at HLA-A, B, and DR beta 1
PATIENT CHARACTERISTICS:
Age:
- Under 60 (over 60 considered on case-by-case basis)
Performance status:
- Karnofsky 70-100%
- Lansky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- AST and ALT less than 2 times upper limit of normal
- Bilirubin less than 1.5 mg/dL unless liver is involved with disease
Renal:
- Creatinine normal
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- Asymptomatic with no prior risk factors OR
- LVEF greater than 50% if symptomatic
Pulmonary:
- Asymptomatic with no prior risk factors OR
- Diffusion capacity greater than 50% predicted (corrected for hemoglobin) if symptomatic
Other:
- No active uncontrolled viral, bacterial, or fungal infection
- Not pregnant or nursing
- Negative pregnancy test
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- More than 6 months since prior allogeneic or autologous stem cell transplantation
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014469
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Trudy N. Small, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00014469 History of Changes |
| Other Study ID Numbers: | 00-126, P30CA008748, P01CA023766, MSKCC-00126, NCI-H01-0070 |
| Study First Received: | April 10, 2001 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase 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 refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
chronic myelomonocytic leukemia acute undifferentiated leukemia secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes graft versus host disease refractory cytopenia with multilineage dysplasia juvenile myelomonocytic leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia, BCR-ABL1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Immune System Diseases Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Busulfan Melphalan Methotrexate |
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 23, 2013