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Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

Phase 2
18 Years
65 Years
Not Enrolling
Breast Cancer, Ovarian Cancer

Thank you

Trial Information

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

The Study Drugs:

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.

The combination of standard chemotherapy drugs (fludarabine and melphalan) used for this
study may help to improve the chances of your body accepting the stem cell transplant.
Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic
material of cells) and weaken the immune system so that stem cells can stay in your body.
Melphalan is designed to damage the cancer cells' DNA.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will have a central venous
catheter inserted. A central venous catheter is a sterile flexible tube that will be placed
into a large vein while you are under local anesthesia. Your doctor will explain this
procedure to you in more detail, and you will be required to sign a separate consent form
for this procedure.

You will receive chemotherapy with bevacizumab, fludarabine, and melphalan in order to
prepare for the stem cell transplant.

On Day 1, you will receive bevacizumab through a needle in your vein over 30 minutes.

On Days 2-6, you will receive fludarabine by vein over 30 minutes.

On Day 5-6, you will receive melphalan by vein over 30 minutes.

On Day 7, you will receive no study drugs.

Stem Cell Transplant and Post-Transplant Drug Administration:

On Day 8, you will have a stem cell transplant. Your study doctor will explain this
procedure to you in more detail and you will sign a separate consent form.

After the transplant, you will receive the drugs tacrolimus and methotrexate. Tacrolimus
and methotrexate are used to prevent graft versus host disease (GVHD), a condition that
occurs when the transplanted cells attack the normal cells in the body.

Tacrolimus will be given by vein non-stop (24 hours a day) until you are able to take
medications by mouth. Once you are able to take medications by mouth, your doctor will tell
you how and when to take the oral medication. You will receive tacrolimus for 2-3 months.
During the last month that tacrolimus is given, the dose will be lowered gradually.

Methotrexate will be given by vein over a few seconds on Days 9, 11, and 14. An additional
dose of methotrexate will be given on Day 19 if your donor is your parent, child, or an
unrelated family member.

If GVHD does occur, the GVHD will be treated with methylprednisolone by vein or by mouth, as
needed. You may also be given steroid cream to use on the skin, if needed.

Starting at least 3 weeks after the transplant, as soon as your blood counts recover, you
will receive bevacizumab every 2 weeks by vein over 30 minutes.

Post-Transplant Procedures:

You must stay in the hospital for about 3-4 weeks beginning on Day 1. While you are in the
hospital, blood (about 2 teaspoons) will be drawn for routine tests every day.

You must stay in the Houston area for about 100 days after the transplant. Once a month
during the 100 days after the transplant, and then every 3 months for the first year, you
will have scans to check the status of the disease. The study doctor will decide which
scans are necessary (chest x-rays, CT scans, and/or bone scans). You may also have a bone
marrow aspirate and biopsy at these times. The bone marrow aspirate and biopsy would only
be performed if your bone marrow was shown to be involved with the disease at the time of

If the disease is still present at 2 months after the transplant, and you do not have GVHD,
you will stop receiving tacrolimus within 2 weeks. After that, if the disease is still
present after another 6 weeks, and you do not have GVHD, you may receive an infusion of
donor lymphocytes (a type of white blood cell) by vein over about 30 minutes. This treatment
with white blood cells may be repeated 2 more times with 6 weeks between each infusion.

Length of Study:

You will be taken off-study after 1 year.

Follow-Up Visits:

You will have follow-up visits as per standard of care.

This is an investigational study. The use of bevacizumab in transplant patients is not FDA
approved. Melphalan and fludarabine are FDA approved and commercially available for
transplant patients. Up to 18 patients will take part in this study. All will be enrolled
at M. D. Anderson.

Inclusion Criteria:

1. From Age 18 to Age
2. Patients must have one of the following diseases. 1) metastatic breast cancer which
achieved a tumor response (complete response (CR) or partial response (PR)) by
pre-transplant therapy. For bone only metastatic breast cancer, a tumor response of
stable disease (SD) is accepted. 2) low grade advanced ovarian cancer 3) high grade
advanced ovarian cancer which achieved antitumor response (CR or PR) by
pre-transplant therapy.

3. Zubrod performance status
4. An HLA-matched (6/6 matches) related donor or unrelated donor (8/8 matches) willing
and able to donate peripheral blood stem cell (PBSC) or bone marrow and/or
lymphocytes by conventional techniques.

5. Requirement of prior treatment. For metastatic renal cell carcinoma (RCC) two prior
treatments, which include targeted therapy (e.g. Sorafenib and Stutent). For breast
and ovarian cancer, one prior treatment which include chemotherapy.

6. Adequate major organ functions.

7. Signed informed consent.

8. Left ventricular ejection fraction >/= 45%. Cardiology clearance is needed if the
patient has left ventricular ejection fraction of < 45%, uncontrolled arrhythmias, or
symptomatic cardiac disease.

9. Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), and carbon
monoxide diffusing capacity (DLCO) >/= 50% of predicted value. Pulmonary clearance is
needed if the patient has FEV1, FVC, or DLCO < 50% of predicted valued or any
symptomatic pulmonary disease.

10. Serum creatinine 40 mL/min.

11. Serum bilirubin upper limit of normal.

Exclusion Criteria:

1. Prior history of allogeneic stem cell transplantation.

2. Life expectancy is severely limited by concomitant illness.

3. Clinically significant active infections.

4. HIV infection.

5. Chronic active hepatitis.

6. Pregnant or lactating women.

7. Presence of, or prior history of multiple brain metastasis. If patient has prior
single brain metastasis treated with complete surgical resection or stereotactic
radiation therapy, radiological imaging has to demonstrate no recurrence or no brain
edema for at least 6 months from the end of the treatment.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Number or participants with no disease progression or death for any reason during first 100 days following transplantation. Participants followed every 3 months for first year.

Outcome Time Frame:

100 days after transplant

Safety Issue:


Principal Investigator

Naoto Ueno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Stem Cell Transplantation
  • Bevacizumab
  • Fludarabine
  • Melphalan
  • Avastin
  • Thymoglobulin
  • ATG
  • Antithymocyte Globulin
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Breast Neoplasms
  • Ovarian Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030