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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Invasive Fungal Infections, Hematologic Malignancies

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Trial Information

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


The Study Drugs:

ABLC is an antifungal drug that is commonly used to treat and/or prevent a variety of
serious invasive fungal infections (IFIs). In this study, ABLC will be used for IFI
prevention.

Posaconazole is a newer antifungal drug that is commonly used to prevent serious IFIs.

Screening Tests:

Before you can receive the study treatment, you will have "screening tests" to help the
doctor decide if you are eligible to take part in this study. The following tests will be
performed:

- If the study doctor and/or your primary doctor feel it is necessary, you will be
checked for signs of IFI (such as fever and pain).

- You will be asked about your medical and surgical history.

- You will be asked about any medications you may have taken in the past 4 weeks.

- You will have a physical exam, including measurement of your vital signs (heart rate,
temperature, breathing rate, blood pressure), weight, and height.

- You will have an electrocardiogram (ECG -- a test that measures the electrical activity
of the heart).

- Blood (about 1 tablespoon) will be drawn for routine tests. Throughout the study,
these routine blood sample may be drawn from your central venous catheter (CVC), if you
have one in place at the time.

- Women who are able to have children must have a negative blood (about 1 teaspoon) or
negative urine pregnancy test.

If your study doctor and/or primary doctor feel it is necessary to make sure you do not
already have an IFI, you will have certain routine diagnostic tests performed. These tests
may include a blood draw (about 1 tablespoon), scans (such as x-rays or computed tomography
[CT] scans), skin tissue biopsy, and/or a bronchoscopy. You will sign a separate consent
for these standard procedures.

To perform a skin tissue biopsy, an area of the skin is numbed with anesthetic, and a small
amount of skin is removed with a special knife.

To perform a bronchoscopy, you will be given drugs to relax, and then a local anesthetic
will be sprayed into your nose and throat to numb those areas. A thin, flexible tube with a
light will be placed through your nose or mouth and into your lungs. A small brush will be
fed through the tube and into your lungs. The brush will gently scrape off samples of lung
tissue. Tweezers will then be fed through the tube to collect the tissue samples. A small
amount of water will be sprayed into your lungs and then suctioned out through the tube to
collect additional tissue samples, mucous samples, and fluid samples if necessary.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to receive either posaconazole or ABLC. You will have an equal
chance (50/50) of being assigned to either group. You and your study doctor will know which
group you are in.

Study Drug Administration:

If you are assigned to the Posaconazole Group, you will take posaconazole 3 times a day by
mouth for up to 6 weeks (Days 1-42). The study doctor will advise you about taking it with
fatty meals and/or nutritional supplements.

If you are assigned to the ABLC Group, you will receive ABLC once a week by vein over 4-6
hours, for up to 6 weeks (from Day 1 through Day 42). If the creatinine level increases,
the dose will be divided into 2 doses per week. The drug may be given in the hospital (if
you are admitted to the hospital before or during the study) or at an outpatient treatment
center.

Study Visits:

Once a week from Day 1 to Day 42, you will have the following procedures performed:

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will be asked about any medications and treatments you may be receiving.

- You will be asked about any IFI symptoms that may have developed. You will also be
asked about any side effects that may have occurred since your last visit. (You should
contact the study doctor and/or study staff right away, if at any time you feel you
have had a side effect.)

If your doctor feels it is necessary at any time in the study, you will have an ECG.

You may have certain routine diagnostic tests performed at any time in the study, if
necessary to confirm you do not have an IFI. These tests may include blood collection
(about 1 tablespoon), scans, skin tissue biopsy, and/or bronchoscopy.

Length of Study:

You will receive study treatment for up to 6 weeks (42 days). If you develop an IFI or any
intolerable side effects, you will be taken off study early. You may also be taken off
study if your neutrophil (a type of white blood cell) counts recover.

End-of-Treatment Visit:

Your End-of-Treatment visit will be on the last day you received the study drug (at most, 42
days after you started). The following procedures will be performed.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- You will have a physical exam, including measurement of vital signs.

- If the study doctor and/or your primary doctor thinks you may have an IFI, routine
diagnostic tests may be performed.

Follow-up Visit:

Your follow up visit will be completed 7 - 14 days after your end-of-treatment visit. The
following procedures will be performed:

- You will be checked for any signs of IFI.

- If your doctor suspects you have an IFI, a scan (such as an x-ray or CT scan) and/or
bronchoscopy may be performed.

- You will be asked about any medications and treatments you may be receiving, and any
side effects you may have had.

- Your vital signs will be checked, and a physical exam may be performed.

- Blood (about 1 tablespoon) will be drawn for routine tests.

- An ECG may be performed.

This is an investigational study. ABLC and posaconazole are FDA approved and commercially
available for the treatment and prevention of IFIs. Posaconazole is FDA approved for the
way it is being used in this study. The study dose and study schedule for ABLC, however, is
considered experimental. Currently, this dose and schedule for ABLC is being used in
research only.

Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity Rate

Outcome Time Frame:

Continually through Follow Up Visit (7-14 Days after End of Treatment)

Safety Issue:

Yes

Principal Investigator

Issam Raad, MD/Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0020

NCT ID:

NCT00750737

Start Date:

June 2008

Completion Date:

June 2012

Related Keywords:

  • Invasive Fungal Infections
  • Hematologic Malignancies
  • 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
  • Neoplasms
  • Mycoses
  • Hematologic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030