Levofloxacin in Preventing Infection in Young Patients Receiving Chemotherapy For Acute Leukemia or Undergoing Stem Cell Transplantation
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Supportive care | Active | 6 months to 21 years | NCI, Other | CDR0000695661 COG-ACCL0934, ACCL0934, NCT01371656 |
Summary
RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
PURPOSE: This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients receiving chemotherapy for acute leukemia or undergoing stem cell transplant.
Further Study Information
OBJECTIVES:
Primary
- To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia.
Secondary
- To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis.
- To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT.
- To determine whether levofloxacin prophylaxis reduces the incidence of fever with neutropenia, severe infection, and death from bacterial infection.
- To assess the safety of levofloxacin prophylaxis, with specific attention to musculoskeletal disorders including tendinopathy and tendon rupture.
- To assess the impact of prophylactic levofloxacin on the incidence of Clostridium difficile-associated diarrhea (CDAD), and the incidence of microbiologically documented invasive fungal infections (IFI).
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (de novo acute myeloid leukemia [AML] vs secondary AML vs relapsed AML vs relapsed acute lymphoblastic leukemia [ALL]), and therapy (undergoing autologous HSCT vs undergoing allogeneic HSCT). Patients are randomized to 1 of 2 treatment groups.
- Arm I: Patients receive levofloxacin orally (PO) or IV over 60-90 minutes once or twice daily beginning on day 1 during 2 consecutive courses of chemotherapy or beginning on day -2 during hematopoietic stem cell transplantation (HSCT) and continuing until blood counts recover.
- Arm II: Patients receive established standard of care and receive chemotherapy or HSCT as patients in arm 1.
Musculoskeletal assessment is conducted at baseline and at 2 and 12 months.
Patients may undergo perirectal or stool swab collection for ancillary studies.
After completion of study therapy, patients are followed up for 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Patients must fit 1 of the following categories:
- Chemotherapy patients
- Scheduled to receive at least 2 consecutive courses (not required to be the first 2 courses) of intensive chemotherapy for de novo, relapsed, or secondary acute myeloid leukemia (AML), or relapsed acute lymphoblastic leukemia (ALL)
- For the purposes of this study, "intensive chemotherapy" is defined as regimens that are predicted by the local Investigator to cause neutropenia for > 7 days including, but not limited to:
- Treatment with "4-drug induction" (anthracycline, vincristine, asparaginase, and steroid)
- High-dose cytarabine, anthracycline/cytarabine, or ifosfamide/etoposide
- Clofarabine-containing regimens
- Stem cell transplantation patients*
- Scheduled to receive at least 1 myeloablative autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
- For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days NOTE: *Patients with AML or ALL who were enrolled on this study during intensive chemotherapy are not eligible to be enrolled during HSCT.
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine clearance or radioisotope GFR > 70 mL/min OR serum creatinine based on age and/or gender as follows:
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to < 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
- No patients with an allergy to quinolones
- No patients with chronic active arthritis
- No patients with a known pathologic prolongation of the QTc
- No females who are pregnant or breast feeding
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No patients scheduled to receive non-intensive or palliative chemotherapy
- No patients undergoing non-myeloablative hematopoietic stem cell transplantation (HSCT)
- No patients being treated with antibacterial agents, other than cotrimoxazole for Pneumocystitis jiroveci (PCP) prophylaxis
Trial Lead Organizations/Sponsors
Children's Oncology Group
National Cancer Institute| Sarah Alexander |  | Study Chair |
Trial Sites
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| U.S.A. | |||
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| Arkansas | |||
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| Little Rock | |||
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| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | |||
| David L Becton | Ph: 501-364-7373 | ||
| California | |||
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| Arcadia | |||
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| Children's Oncology Group | |||
| Sarah W Alexander | Ph: 416-813-7654 | ||
| Email: sarah.alexander@sickkids.ca | |||
| Downey | |||
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| Southern California Permanente Medical Group | |||
| Robert M Cooper | Ph: 626-564-3455 | ||
| Duarte | |||
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| City of Hope Comprehensive Cancer Center | |||
| Anna B Pawlowska | Ph: 800-826-4673 | ||
| Email: becomingapatient@coh.org | |||
| Loma Linda | |||
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| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |||
| Antranik A Bedros | Ph: 909-558-3375 | ||
| Long Beach | |||
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| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | |||
| Amanda M Termuhlen | Ph: 562-933-5437 | ||
| Los Angeles | |||
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| Childrens Hospital Los Angeles | |||
| Leo Mascarenhas | Ph: 323-361-4110 | ||
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |||
| Carole H Hurvitz | Ph: 310-423-8965 | ||
| San Diego | |||
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| Rady Children's Hospital - San Diego | |||
| William D Roberts | Ph: 858-966-5934 | ||
| San Francisco | |||
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| UCSF Helen Diller Family Comprehensive Cancer Center | |||
| Christopher C Dvorak | Ph: 877-827-3222 | ||
| Delaware | |||
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| Wilmington | |||
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| Alfred I. duPont Hospital for Children | |||
| Christopher N Frantz | Ph: 302-651-5755 | ||
| District of Columbia | |||
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| Washington | |||
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| Children's National Medical Center | |||
| Jeffrey S Dome | Ph: 202-884-2549 | ||
| Florida | |||
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| Fort Myers | |||
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| Lee Cancer Care of Lee Memorial Health System | |||
| Emad K Salman | Ph: 239-343-5333 | ||
| Jacksonville | |||
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| Nemours Children's Clinic | |||
| Eric S Sandler | Ph: 904-697-3529 | ||
| Orlando | |||
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| Nemours Children's Clinic - Orlando | |||
| Ramamoorthy Nagasubramanian | Ph: 407-650-7150 | ||
| Pensacola | |||
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| Nemours Children's Clinic - Pensacola | |||
| Jeffrey H Schwartz | Ph: 904-697-3529 | ||
| Saint Petersburg | |||
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| All Children's Hospital | |||
| Gregory A Hale | Ph: 727-767-2423 | ||
| Email: HamblinF@allkids.org | |||
| Georgia | |||
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| Atlanta | |||
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| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |||
| Howard M Katzenstein | Ph: 888-785-1112 | ||
| Augusta | |||
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| Medical College of Georgia Cancer Center | |||
| Colleen H McDonough | Ph: 706-721-1663 | ||
| Email: cancer@georgiahealth.edu | |||
| Illinois | |||
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| Chicago | |||
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| University of Illinois Cancer Center | |||
| Mary L Schmidt | Ph: 312-355-3046 | ||
| Indiana | |||
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| Indianapolis | |||
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| Riley's Children Cancer Center at Riley Hospital for Children | |||
| Robert J Fallon | Ph: 317-274-2552 | ||
| St. Vincent Indianapolis Hospital | |||
| Bassem I Razzouk | Ph: 317-338-2194 | ||
| Iowa | |||
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| Des Moines | |||
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| Blank Children's Hospital | |||
| Wendy L Woods-Swafford | Ph: 888-823-5923 | ||
| Email: ctsucontact@westat.com | |||
| Kentucky | |||
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| Lexington | |||
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| University of Kentucky Chandler Medical Center | |||
| Martha F Greenwood | Ph: 859-257-3379 | ||
| Louisville | |||
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| Kosair Children's Hospital | |||
| Alexandra C Cheerva | Ph: 866-530-5516 | ||
| Louisiana | |||
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| New Orleans | |||
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| Ochsner Cancer Institute at Ochsner Clinic Foundation | |||
| Craig Lotterman | Ph: 888-562-4763 | ||
| Tulane Cancer Center at Tulane University Hospital and Clinic | |||
| Tammuella C Singleton | Ph: 504-988-6121 | ||
| Maryland | |||
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| Baltimore | |||
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| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |||
| Joseph M Wiley | Ph: 410-601-6120 | ||
| Email: pridgely@lifebridgehealth.org | |||
| Greenebaum Cancer Center at University of Maryland Medical Center | |||
| Teresa A York | Ph: 800-888-8823 | ||
| Michigan | |||
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| Lansing | |||
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| Breslin Cancer Center at Ingham Regional Medical Center | |||
| Renuka Gera | Ph: 517-334-2765 | ||
| Minnesota | |||
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| Minneapolis | |||
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| Children's Hospitals and Clinics of Minnesota - Minneapolis | |||
| Bruce C Bostrom | Ph: 612-813-5193 | ||
| Mississippi | |||
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| Jackson | |||
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| University of Mississippi Cancer Clinic | |||
| Gail C Megason | Ph: 601-815-6700 | ||
| Missouri | |||
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| Saint Louis | |||
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| David C. Pratt Cancer Center at St. John's Mercy | |||
| Bethany G. Sleckman | Ph: 913-948-5588 | ||
| Nebraska | |||
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| Omaha | |||
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| Children's Hospital | |||
| Minnie Abromowitch | Ph: 402-955-3949 | ||
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |||
| Peter F Coccia | Ph: 800-999-5465 | ||
| Nevada | |||
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| Las Vegas | |||
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| CCOP - Nevada Cancer Research Foundation | |||
| Jonathan Bernstein | Ph: 702-384-0013 | ||
| New Jersey | |||
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| Hackensack | |||
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| Hackensack University Medical Center Cancer Center | |||
| Steven H Diamond | Ph: 201-996-2879 | ||
| New Brunswick | |||
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| Saint Peter's University Hospital | |||
| Stanley Calderwood | Ph: 732-745-8600ext6163 | ||
| Email: kcovert@saintpetersuh.com | |||
| New Mexico | |||
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| Albuquerque | |||
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| University of New Mexico Cancer Center | |||
| Koh B Boayue | Ph: 505-272-6972 | ||
| New York | |||
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| Bronx | |||
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| Montefiore Medical Center | |||
| Rosanna J Ricafort | Ph: 718-904-2730 | ||
| Email: aecc@aecom.yu.edu | |||
| Buffalo | |||
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| Roswell Park Cancer Institute | |||
| Barbara J Bambach | Ph: 877-275-7724 | ||
| North Carolina | |||
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| Winston-Salem | |||
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| Wake Forest University Comprehensive Cancer Center | |||
| Thomas W McLean | Ph: 336-713-6771 | ||
| Ohio | |||
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| Akron | |||
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| Akron Children's Hospital | |||
| Steven J Kuerbitz | Ph: 330-543-3193 | ||
| Columbus | |||
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| Nationwide Children's Hospital | |||
| Mark A Ranalli | Ph: 614-722-2708 | ||
| Dayton | |||
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| Dayton Children's - Dayton | |||
| Emmett H Broxson | Ph: 800-228-4055 | ||
| Oklahoma | |||
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| Oklahoma City | |||
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| Oklahoma University Cancer Institute | |||
| Rene Y McNall-Knapp | Ph: 405-271-4272 | ||
| Email: julie-traylor@ouhsc.edu | |||
| Pennsylvania | |||
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| Danville | |||
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| Geisinger Cancer Institute at Geisinger Health | |||
| Jeffrey S Taylor | Ph: 570-271-5251 | ||
| Philadelphia | |||
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| Children's Hospital of Philadelphia | |||
| L. C Bailey | Ph: 215-590-2810 | ||
| Pittsburgh | |||
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| Children's Hospital of Pittsburgh of UPMC | |||
| Arthur K Ritchey | Ph: 412-692-5573 | ||
| South Carolina | |||
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| Columbia | |||
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| Palmetto Health South Carolina Cancer Center | |||
| Ronnie W. Neuberg | Ph: 803-434-3680 | ||
| South Dakota | |||
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| Sioux Falls | |||
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| Sanford Cancer Center at Sanford USD Medical Center | |||
| Kayelyn J Wagner | Ph: 605-328-1367 | ||
| Texas | |||
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| Corpus Christi | |||
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| Driscoll Children's Hospital | |||
| M. C Johnson | Ph: 361-694-5311 | ||
| Dallas | |||
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| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||
| Naomi J Winick | Ph: 214-648-7097 | ||
| Fort Worth | |||
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| Cook Children's Medical Center - Fort Worth | |||
| Mary Meaghan P Granger | Ph: 682-885-2103 | ||
| San Antonio | |||
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| Methodist Children's Hospital of South Texas | |||
| Jaime Estrada | Ph: 210-575-7000 | ||
| University of Texas Health Science Center at San Antonio | |||
| Anne-Marie R Langevin | Ph: 210-567-0653 | ||
| Email: che@uthscsa.edu | |||
| Virginia | |||
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| Norfolk | |||
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| Children's Hospital of The King's Daughters | |||
| Eric J Lowe | Ph: 757-668-7243 | ||
| Washington | |||
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| Tacoma | |||
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| Madigan Army Medical Center - Tacoma | |||
| Melissa A Forouhar | Ph: 253-968-0129 | ||
| Email: mamcdci@amedd.army.mil | |||
| Wisconsin | |||
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| Marshfield | |||
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| Marshfield Clinic - Marshfield Center | |||
| Michael J McManus | Ph: 715-389-4457 | ||
| Canada | |||
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| Ontario | |||
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| Kingston | |||
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| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |||
| Mariana P Silva | Ph: 613-544-2630 | ||
| Toronto | |||
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| Hospital for Sick Children | |||
| Ronald M Grant | Ph: 416-813-7654ext2027 | ||
| Email: jason.mcguire@sickkids.ca | |||
| Quebec | |||
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| Montreal | |||
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| Montreal Children's Hospital at McGill University Health Center | |||
| Sharon B Abish | Ph: 514-412-4445 | ||
| Email: info@thechildren.com | |||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01371656
Information obtained from ClinicalTrials.gov on November 25, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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