Viewing Study NCT00073879



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00073879
Status: COMPLETED
Last Update Posted: 2015-01-29
First Post: 2003-12-10

Brief Title: Fludarabine Cyclophosphamide and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma Kidney Cancer Undergoing Allogeneic Stem Cell Transplantation
Sponsor: Baylor College of Medicine
Organization: Baylor College of Medicine

Study Overview

Official Title: Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
Status: COMPLETED
Status Verified Date: 2015-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Drugs used in chemotherapy such as fludarabine and cyclophosphamide use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy Sometimes the transplanted cells can reject the bodys normal tissues Alemtuzumab and tacrolimus may prevent this from happening

PURPOSE Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma kidney cancer
Detailed Description: OBJECTIVES

Determine the safety and feasibility of fludarabine cyclophosphamide and alemtuzumab in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched allogeneic stem cell transplantation

OUTLINE This is a pilot multicenter study

Conditioning Patients receive fludarabine IV over 30 minutes on days -6 to -2 cyclophosphamide IV over 2 hours on days -6 and -5 and alemtuzumab IV on days -4 to -2
Allogeneic transplantation Allogeneic stem cells are infused on day 0 Patients receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for approximately 30 days

Patients are followed weekly for 100 days and then at 6 12 18 24 36 48 and 60 months after transplantation

PROJECTED ACCRUAL A total of 20 patients 10 with HLA-identical related donors and 10 with matched unrelated donors will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link




BCM-H-8447 None None None