Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00523809
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10 mg/kg IV Daily Over 30 Minutes for 1 Day
  • Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
    Stem Cell Transplantation on Day 8.
  • Fludarabine — DRUG
    25 mg/m\^2 IV Daily Over 30 Minutes for 5 Days
  • Melphalan — DRUG
    70 mg/m\^2 IV Daily Over 30 Minutes for 2 Days
  • Thymoglobulin — DRUG
    0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1.

Study Details

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.

Key Dates

First listed
Sep 3, 2007
Start date
Aug 31, 2007
Status verified
Dec 2012
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 100 days after transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T.M.D. Anderson Cancer CenterHoustonTexas77030-

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