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Study Summary
No. 2006-0873:.......Breast; Kidney; Ovary......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy
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Study Summary Title
Study Summary
Number:
2006-0873
Study Title:Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation with Bevacizumab for Advanced Solid Tumor
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Physician New Patient Referral
Name:Naoto UenoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Stem Cell Transplantation and Cellular TherapyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-8754
Contact us about clinical trials
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General Information
Disease Group:Breast
Kidney
Ovary
Supported By:N/A
Phase of Study:Phase IIReturn
Visit:
Per BMT standard. At least twice a week.
Treatment
Agents:
Bevacizumab
Fludarabine
Melphalan
Home Care:No.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Per BMT standard. 3-4 weeks as inpatient & 100 days stay at Houston after the
day of transplant.
Description/
Intervention:
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.
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Study Objectives / Outcomes
    Primary Objectives:
    1. To determine the safety of nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) with bevacizumab-containing conditioning regimen.
    2. To determine the progression-free survival (PFS) of NST with bevacizumab-containing conditioning regimen.

    Secondary Objectives:
    3. To monitor serum levels of VEGF and other cytokines/chemokines post-NST.
    4. To determine the rate and extent of dendritic cell recovery and phenotypic characteristics of dendritic cells in the blood and bone marrow post-NST.
    5. To discover putative antigen that allogeneic lymphocytes may recognize.
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Study Status Information
Study Activation / Registration Date:08/30/2007
IRB Review and Approval Date:03/21/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) From Age 18 to Age </= 65 years old.

2) Patients must have one of the following diseases. 1) metastatic breast cancer which achieved a tumor response (CR or PR) by pre-transplant therapy. For bone only metastatic breast cancer, a tumor response of 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 </= 1.

4) An HLA-matched (6/6 matches) related donor or unrelated donor (8/8 matches) willing and able to donate PBSC or bone marrow and/or lymphocytes by conventional techniques.

5) Requirement of prior treatment. For metastatic 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) FEV1, FVC, and 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 </= 2.0 mg/dL, or creatinine clearance > 40 mL/min.

11) Serum bilirubin </= 1.5 mg/dL, and SGPT </= 3 x 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.

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Links
Registration Number: NCT00523809
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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