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Trial record 63 of 580 for:    Advanced | cancer | bevacizumab

Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

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ClinicalTrials.gov Identifier: NCT00523809
Recruitment Status : Terminated (Slow accrual.)
First Posted : September 3, 2007
Results First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor
Study Start Date : August 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 100 days after transplant ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00523809     History of Changes
Other Study ID Numbers: 2006-0873
First Posted: September 3, 2007    Key Record Dates
Results First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: December 2012

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Bevacizumab
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Fludarabine
Fludarabine phosphate
Melphalan
Thymoglobulin
Antilymphocyte Serum
Vidarabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antiviral Agents