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Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, March 2009
First Received: September 10, 2008   Last Updated: March 17, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Enzon Pharmaceuticals, Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00750737
  Purpose

The objective of this study is to compare the safety and efficacy of ABLC versus oral Posaconazole in the prevention of invasive fungal infections in high risk patients with hematologic malignancies or hematopoietic stem cell transplant.

Primary objective is to demonstrate the low toxicity rate and low rate of invasive fungal infections associated with ABLC or Posaconazole prophylaxis.

Secondary objective will be to compare the cost effectiveness of these two prophylactic regimens.


Condition Intervention Phase
Invasive Fungal Infections
Hematologic Malignancies
Drug: Posaconazole
Drug: Amphotericin B Liquid Complex (ABLC)
Phase III

MedlinePlus related topics: Bone Marrow Transplantation Cancer Fungal Infections Molds
Drug Information available for: Lipids Posaconazole Amphotericin B
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase III Clinical Trial of Oral Posaconazole 3 Times/Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) for Prevention of Invasive Fungal Infections In Patients With Hematologic Malignancies & Hematopoietic Stem Cell Transplant

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To compare Noxafil (posaconazole) to Amphotericin B Liquid Complex (ABLC) in patients having blood cancer and/or had a recent/upcoming bone marrow transplant to learn if posaconazole will provide same or better results as ABLC preventing IFIs. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Posaconazole: Experimental Drug: Posaconazole
3 times day by mouth for up to 6 weeks (Days 1-42)
2: ABLC: Experimental Drug: Amphotericin B Liquid Complex (ABLC)
ABLC once a week by vein over 4-6 hours, for up to 6 weeks (from Day 1 through Day 42)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects: 18 years of age or above.
  2. Any allogeneic hematopoietic stem cell transplant (HSCT) patient who is at risk of invasive fungal infection (IFI) within 6 months of the transplant will be eligible for the study according to HSCT institutional anti-fungal prophylaxis guidelines.
  3. Subjects must be willing to give written informed consent and able to adhere to dosing and study visit schedule.
  4. Female subjects of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) at Baseline or within 96 hours before the start of study drug.
  5. Female subjects of childbearing potential must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Acceptable methods of contraception include condoms with/without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD (intrauterine device), oral/injectable hormonal contraceptive, surgical sterilization (e.g. hysterectomy/tubal ligation).

Exclusion Criteria:

  1. Subjects previously treated with antifungal therapy (voriconazole, fluconazole, or itraconazole) for proven or probable IFI within 30 days of enrollment.
  2. Subjects who have taken the following drugs: terfenadine, cisapride, primazide, and ebastine; that are known to interact with azoles and that may lead to life-threatening side effects, within 24 hours before study drug administration. And astemizole within 7 days before study drug administration.
  3. Subjects who have taken the following drugs: cimetidine, rifampin, carbamezapine, phenytoin, rifabutin, barbiturates, isoniazid, and vinca alkaloids (vincristine, vinblastine); that are known to lower the serum concentration/efficacy of azole antifungal agents, within 24 hours before study drug administration.
  4. Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents or Amphotericin B.
  5. Subjects on other nephrotoxic agents (e.g. foscarnet).
  6. Patients who are unable to take pills.
  7. Subjects with proven or probable invasive fungal infection.
  8. Subjects with renal insufficiency (estimated creatine clearance less than 50mL/minute at Baseline or likely to require dialysis during the study).
  9. Subjects having ECG with a prolonged QTc interval by manual reading: QTc greater than 500 msec. at Baseline.
  10. Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate amniotransferase (AST), alanine amniotransferase (ALT) and / or a total bilirubin level greater than 3 times the upper limit of normal (ULN).
  11. Women who are breast feeding, pregnant, or intend to become pregnant during the course of the study.
  12. Prior enrollment in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750737

Contacts
Contact: Issam Raad, MD/Professor 713-792-7943

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Enzon Pharmaceuticals, Inc.
Investigators
Principal Investigator: Issam Raad, MD/Professor U.T. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T. M.D. Anderson Cancer Center ( Issam Raad, MD/Professor )
Study ID Numbers: 2007-0020
Study First Received: September 10, 2008
Last Updated: March 17, 2009
ClinicalTrials.gov Identifier: NCT00750737     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Hematologic Malignancies
Blood Cancer
Lymphatic Cancer
Amphotericin B Lipid Complex
Amphotericin B
ABLC
Fungizone
Noxafil
SCH56592
Posaconazole
Invasive fungal infections
IFI
Hematopoietic Stem Cell Transplant
HSCT
Bone Marrow Transplant
Allogeneic hematopoietic stem cell transplant

Study placed in the following topic categories:
Abelcet
Anti-Bacterial Agents
Amphotericin B
Mycoses
Hematologic Neoplasms
Clotrimazole
Hematologic Diseases
Miconazole
Antifungal Agents
Tioconazole
Posaconazole
Liposomal amphotericin B

Additional relevant MeSH terms:
Abelcet
Trypanocidal Agents
Anti-Infective Agents
Communicable Diseases
Amphotericin B
Antiprotozoal Agents
Hematologic Neoplasms
Hematologic Diseases
Infection
Liposomal amphotericin B
Pharmacologic Actions
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Neoplasms
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Amebicides
Posaconazole

ClinicalTrials.gov processed this record on May 07, 2009