Overview

Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

Status:
Terminated

Trial end date:
2011-10-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if giving Avastin (bevacizumab) with standard chemotherapy and a blood stem cell transplant, in patients with an advanced solid tumor, can help to shrink the tumor or slow its growth. The safety of this treatment will also be studied.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Antilymphocyte Serum
Bevacizumab
Fludarabine
Fludarabine phosphate
Melphalan
Thymoglobulin
Vidarabine

Criteria

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.