Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant

NCT ID: NCT00324324

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

moxifloxacin hydrochloride

Moxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Group Type: ACTIVE_COMPARATOR

moxifloxacin hydrochloride

Intervention Type: DRUG

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Sugar pill

Placebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Interventions

moxifloxacin hydrochloride

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Intervention Type: DRUG

Placebo

Moxifloxacin/Placebo 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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®)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD, BCPS, BCOP

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

P30CA069533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-TPI-02027-L

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU 0285

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000472877

Identifier Type: -

Identifier Source: org_study_id