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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Kidney Cancer	Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy	Phase II

MedlinePlus related topics:

Bone Marrow Transplantation Cancer Kidney Cancer

ChemIDplus related topics:

Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate (complete and partial response) at 6 and 12 months after transplantation [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years [ Designated as safety issue: No ]
Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years [ Designated as safety issue: No ]
Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years [ Designated as safety issue: No ]
Toxicity as measured by CTC AE v 3.0 100 days after transplantation [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	June 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243009

Locations


United States, Oregon
	Cancer Institute at Oregon Health and Science University
	Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

Oregon Health and Science University Cancer Institute

National Cancer Institute (NCI)

Investigators


Study Chair:	Brandon M. Hayes-Lattin, MD	Oregon Health and Science University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000447207, OHSU-ONC-03077-L, OHSU-1282
First Received:	October 20, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00243009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent renal cell cancer

stage IV renal cell cancer

clear cell renal cell carcinoma

Study placed in the following topic categories:

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Urogenital Neoplasms

Fludarabine monophosphate

Renal cancer

Urologic Neoplasms

Kidney cancer

Cyclosporins

Recurrence

Carcinoma

Urologic Diseases

Kidney Neoplasms

Mycophenolate mofetil

Carcinoma, Renal Cell

Fludarabine

Kidney Diseases

Adenocarcinoma

Clear cell renal cell carcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 09, 2008

Sponsors and Collaborators:	Oregon Health and Science University Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00243009