Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00523809
First received: August 31, 2007
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Ovarian Cancer
Drug: Bevacizumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Fludarabine
Drug: Melphalan
Drug: Thymoglobulin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: 100 days after transplant ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: August 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + Fludarabine + Melphalan
Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
Drug: Bevacizumab
10 mg/kg IV Daily Over 30 Minutes for 1 Day
Other Names:
  • Avastin™
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Stem Cell Transplantation on Day 8.
Other Name: NST
Drug: Fludarabine
25 mg/m^2 IV Daily Over 30 Minutes for 5 Days
Other Name: Fludarabine Phosphate
Drug: Melphalan
70 mg/m^2 IV Daily Over 30 Minutes for 2 Days
Drug: Thymoglobulin
0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.
Other Names:
  • ATG
  • Antithymocyte Globulin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523809

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00523809     History of Changes
Other Study ID Numbers: 2006-0873
Study First Received: August 31, 2007
Results First Received: December 21, 2012
Last Updated: December 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Ovarian Cancer
Stem Cell Transplantation
Bevacizumab
Fludarabine
Melphalan
Avastin
Thymoglobulin
ATG
Antithymocyte Globulin
Allogeneic Hematopoietic Stem Cell Transplantation
AHSCT

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antibodies, Monoclonal
Antilymphocyte Serum
Melphalan
Fludarabine monophosphate
Fludarabine
Bevacizumab
Vidarabine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Myeloablative Agonists
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on July 23, 2014