Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant
This study has been terminated.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00324324
First received: May 10, 2006
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Infection Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor |
Drug: moxifloxacin hydrochloride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
neuroblastoma
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Antibiotics
Bacterial Infections
Breast Cancer
Cancer
Cancer and Pregnancy
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
U.S. FDA Resources
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: 1 to 120 days post bone marrow transplant ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of bacteremia [ Time Frame: 1 to 120 days post bone marrow transplant ] [ Designated as safety issue: Yes ]
- Incidence and severity of graft-versus-host disease [ Time Frame: 1 to 120 days post bone marrow transplant ] [ Designated as safety issue: Yes ]
- Infection-related mortality [ Time Frame: 1 to 120 days post bone marrow transplant ] [ Designated as safety issue: Yes ]
- Overall mortality [ Time Frame: 1 to 120 days post bone marrow transplant ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: moxifloxacin hydrochloride
Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
|
Drug: moxifloxacin hydrochloride
Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
|
|
Placebo Comparator: Sugar pill
Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue
|
Drug: Placebo
Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
|
Detailed Description:
OBJECTIVES:
Primary
- Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride during the post-engraftment phase in patients who have undergone allogeneic stem cell transplantation. (Pilot study)
- Compare the efficacy, in terms of reducing the incidence of clinically and microbiologically documented bacterial infections, in patients who have undergone allogeneic stem cell transplantation treated with prophylactic moxifloxacin hydrochloride vs placebo during the post-engraftment phase. (Phase III)
Secondary
- Determine the incidence of clinically and microbiologically documented bacterial infections in these patients. (Pilot study)
- Assess the impact of moxifloxacin hydrochloride on the incidence of bacteremia in these patients. (Phase III)
- Compare the percentage of time on systemic antibiotics and days hospitalized in patients treated with these regimens. (Phase III)
- Compare the incidence of veno-occlusive disease of the liver in patients treated with these regimens. (Phase III)
- Compare the incidence and severity of graft-versus-host disease in patients treated with these regimens. (Phase III)
- Compare the infection-related mortality and overall mortality of patients treated with these regimens.
OUTLINE: This is a pilot study followed by a randomized, double-blind, placebo-controlled, multicenter phase III study. Patients are stratified according to gender and race (white vs. non-white). The first 20 patients are assigned to the pilot study.
Patients assigned to the pilot study receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from allogeneic stem cell transplantation (ASCT) and continuing until day 100 post-transplantation in the absence of disease progression or unacceptable toxicity. Subsequent patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral moxifloxacin hydrochloride once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.
- Arm II: Patients receive oral placebo once daily beginning after neutrophil recovery (ANC > 1,500/mm³) from ASCT and continuing until day 100 post-transplantation.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at day 120 post-transplantation.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT)
- Must not be undergoing a nonmyeloablative ASCT
- Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol
- No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed)
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 100 days
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No known hypersensitivity to fluoroquinolones
- No prolonged QTc interval on EKG (i.e., QTc > 440 milliseconds)
- No uncontrolled hypokalemia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics
- No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324324
Locations
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Joseph Bubalo, PharmD, BCPS, BCOP | OHSU Knight Cancer Institute |
More Information
Additional Information:
Publications:
Bubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 2007.
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00324324 History of Changes |
| Other Study ID Numbers: | CDR0000472877, P30CA069533, OHSU-TPI-02027-L, OHSU 0285 |
| Study First Received: | May 10, 2006 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by OHSU Knight Cancer Institute:
|
infection adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia, BCR-ABL negative blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia primary myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia |
chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue myelodysplastic/myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Bacterial Infections Breast Neoplasms Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neuroblastoma Ovarian Neoplasms Trophoblastic Neoplasms |
Lymphoma, Large-Cell, Immunoblastic Neoplasms, Germ Cell and Embryonal Gestational Trophoblastic Neoplasms Myelodysplastic-Myeloproliferative Diseases Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013