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AzTrials

Breast CancerPhase 3NCT00324324

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

A Phase 3 study testing moxifloxacin hydrochloride in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
moxifloxacin hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
1 siteUnited States
Study dates
May 2006to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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®)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
moxifloxacin hydrochloride, Placebo
Keywords
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
Medical subject headings
Breast Neoplasms, Myeloproliferative Disorders, Gestational Trophoblastic Disease, Infections, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moxifloxacin hydrochlorideDrug

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

  • PlaceboDrug

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

Study groups in NCT00324324
Study groupRoleWhat they receive
moxifloxacin hydrochlorideActive comparatorMoxifloxacin 400 mg capsule orally once a day through D+100 after bone marrow transplant, then discontinue
Receives: Drug: moxifloxacin hydrochloride
Sugar pillPlacebo comparatorPlacebo 1 capsule orally once a day through D+100 after bone marrow transplant, then discontinue
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Measured: 1 to 120 days post bone marrow transplant

Secondary outcomes (4)

  1. Incidence of bacteremia

    Measured: 1 to 120 days post bone marrow transplant

  2. Incidence and severity of graft-versus-host disease

    Measured: 1 to 120 days post bone marrow transplant

  3. Infection-related mortality

    Measured: 1 to 120 days post bone marrow transplant

  4. Overall mortality

    Measured: 1 to 120 days post bone marrow transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2007
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324324
Sponsor's protocol ID
CDR0000472877
Other IDs
P30CA069533, OHSU-TPI-02027-L, OHSU 0285
Status last verified
May 2017
First submitted
10 May 2006
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing moxifloxacin hydrochloride in people with Breast Cancer and Chronic Myeloproliferative Disorders, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: 1 to 120 days post bone marrow transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00324324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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