Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
Condition: Breast Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms
Intervention: Bevacizumab; Allogeneic Hematopoietic Stem Cell Transplantation; Fludarabine; Melphalan; Thymoglobulin
Intervention description: 10 mg/kg IV Daily Over 30 Minutes for 1 Day; Stem Cell Transplantation on Day 8.; 25 mg/m^2 IV Daily Over 30 Minutes for 5 Days; 70 mg/m^2 IV Daily Over 30 Minutes for 2 Days; 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.
Intervention MeSH terms: Bevacizumab; Fludarabine; Fludarabine phosphate; Melphalan; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Breast Cancer; Ovarian Cancer; Stem Cell Transplantation; Bevacizumab; Fludarabine; Melphalan; Avastin; Thymoglobulin; ATG; Antithymocyte Globulin; Allogeneic Hematopoietic Stem Cell Transplantation; AHSCT

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.
    

Eligibility criteria:

        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 (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 </= 1.

          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 </= 2.0 mg/dL, or creatinine clearance > 40 mL/min.

         11. Serum bilirubin </= 1.5 mg/dL, and serum glutamic-pyruvic transaminase (SGPT) </= 3 *
             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.