Clinical trial NCT00073879: Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Official title: Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2003-12-11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with treatment related mortality
timeFrame: 100
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Uday Popat, MD
role: STUDY_CHAIR
References: