Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Kidney Cancer Clinical Trial

Official title:

Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00243009
• Other study ID #: CDR0000447207
• Secondary ID: OHSU-ONC-03077-L
• Status: Terminated
• Phase: Phase 2
• First received: October 20, 2005
• Last updated: May 24, 2012
• Start date: June 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2010
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

• Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and total-body irradiation followed by allogeneic hematopoietic stem cell transplantation, in terms of 6-month and 12-month response rate, in patients with unresectable metastatic renal cell carcinoma.

OUTLINE:

• Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2 and total-body irradiation (TBI) on day 0.

• Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo AHSCT on day 0.

• Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 followed by a taper until day 81. Patients also receive oral mycophenolate mofetil twice daily on days 0-27 (if patient has a related donor) OR three times daily on days 0-29 and then twice daily on days 30-149 followed by additional tapering until day 180 (if patient has an unrelated donor).

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:

• Clear cell

• Papillary

• Medullary

• Metastatic disease

• Not amenable to curative surgery

• No CNS metastases

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin < 2 times upper limit of normal (ULN)

• AST or ALT < 4 times ULN

Renal

• Creatinine clearance > 50 mL/min

Cardiovascular

• LVEF > 35%

• No symptomatic congestive heart failure

Pulmonary

• DLCO > 40% of predicted OR

• Total lung capacity or FEV_1 > 30% of predicted

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 30 days since prior biologic therapy

Chemotherapy

• More than 30 days since prior chemotherapy

Radiotherapy

• More than 30 days since prior radiotherapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• cyclosporine

• fludarabine phosphate

• mycophenolate mofetil

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (complete and partial response) at 6 and 12 months after transplantation			No
Secondary	Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years			No
Secondary	Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years			No
Secondary	Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years			No
Secondary	Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years			No
Secondary	Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years			No
Secondary	Toxicity as measured by CTC AE v 3.0 100 days after transplantation			Yes