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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, September 2008
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.


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

MedlinePlus related topics: Cancer Fungal Infections Molds
Drug Information available for: Amphotericin B Lipids Posaconazole
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: No ]

Secondary Outcome Measures:
  • The safety of these drugs will also be studied. [ 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)

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  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. Disease definition: Anticipated or documented prolonged neutropenic (ANC<500) at Baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to: 1) Hematopoietic stem cell transplant; 2) Intensive induction-remission chemotherapy for a new diagnosis of acute leukemia, myelodysplastic syndrome; 3) Reinduction of acute leukemia after primary relapse 4) Lymphoma requiring induction chemotherapy.
  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 that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, primozide, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 7 days before entry).
  3. Subjects who have taken the following drugs that are known to lower the serum concentration/efficacy of azole antifungal agents: cimetidine, rifampin, carbamezapine, phenytoin, rifabutin, barbiturates, isoniazid, and vinca alkaloids (vincristine, vinblastine) at entry or within 24 hours before entry.
  4. Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents or Amphotericin B.
  5. Patients who are unable to take pills.
  6. Subjects with proven or probable invasive fungal infection.
  7. Subjects with renal insufficiency (estimated creatine clearance less than 20mL/minute at Baseline or likely to require dialysis during the study).
  8. Subjects having ECG with a prolonged QTc interval by manual reading: QTc greater than 500 msec. at Baseline.
  9. 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).
  10. Women who are breast feeding, pregnant, or intend to become pregnant during the course of the study.
  11. 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

U.T. M.D. Anderson website  This link exits the ClinicalTrials.gov site

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: September 10, 2008
ClinicalTrials.gov Identifier: NCT00750737  
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
ABLC
Noxafil
Posaconazole
Invasive fungal infections
Hematopoietic Stem Cell Transplant
Bone Marrow Transplant

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

Additional relevant MeSH terms:
Trypanocidal Agents
Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Antiparasitic Agents
Neoplasms by Site
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on January 16, 2009