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NCT Number: NCT00073879

Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation

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 body's 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).

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Key information

Conditions

Kidney Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of recurrent or metastatic renal cell carcinoma
  • Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2
  • Clinically evident and followable disease
  • Availability of 1 of the following compatible donors:
  • Related HLA-identical or 1-Ag mismatched donor
  • Unrelated HLA-A, B, DRB1-matched donor

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 70-100%

Life expectancy

  • No concurrent illness that severely limits life expectancy

Hematopoietic

  • Not specified

Hepatic

  • No episode of hepatitis within the past month
  • No evidence of chronic active hepatitis or cirrhosis

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

  • LVEF at least 40%
  • No uncontrolled arrhythmias
  • No symptomatic cardiac disease

Pulmonary

  • FEV_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease)

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Treatment and study plan

Alemtuzumab

Biological

graft-versus-tumor induction therapy

Biological

Cyclophosphamide

Drug

fludarabine phosphate

Drug

allogeneic bone marrow transplantation

Procedure

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Number of patients with treatment related mortality

    Time frame: 100

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 11, 2003
Registry last updated
Jan 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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