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Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Uday Popat, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Baylor College of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000328247

NCT ID:

NCT00073879

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030