Trials / Unknown

UnknownNCT00295997

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 35 (estimated)

Sponsor: University of California, San Francisco · Academic / Other
Sex: All
Age: 74 Years
Healthy volunteers: Not accepted

Summary

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.

Detailed description

OBJECTIVES: Primary * Determine the treatment-related mortality (TRM) rate at 100 days in patients with hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors. Secondary * Determine the TRM at 12 months in patients treated with this regimen. * Determine the 6-month engraftment rate in patients treated with this regimen. * Determine 1-year overall survival of patients treated with this regimen. OUTLINE: * Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan\* IV over 6 hours on days -4 and -3, and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1. NOTE: \*Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan. * Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. * Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation. Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11\*\*. NOTE: \*\*Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11). * Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active GVHD may receive DLI. A second DLI may be infused \> 8 weeks after the first in the absence of disease response or GVHD. After completion of study treatment, patients are followed periodically for at least 2 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
BIOLOGICAL	filgrastim
BIOLOGICAL	graft-versus-tumor induction therapy
BIOLOGICAL	therapeutic allogeneic lymphocytes
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	fludarabine phosphate
DRUG	methotrexate
DRUG	mycophenolate mofetil
DRUG	tacrolimus
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	nonmyeloablative allogeneic hematopoietic stem cell transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

Start date: 2005-05-01
First posted: 2006-02-24
Last updated: 2014-01-06

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00295997. Inclusion in this directory is not an endorsement.