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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-ONC-03077-L | Other Identifier | OHSU Knight Cancer Institute | |
| OHSU-1282 | Other Identifier | OHSU IRB |
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Due to a lack of a referal base, study was terminated.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE:
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | |||
| fludarabine phosphate | Drug | |||
| mycophenolate mofetil | Drug | |||
| allogeneic bone marrow transplantation | Procedure | |||
| peripheral blood stem cell transplantation | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (complete and partial response) at 6 and 12 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years | ||
| Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years | ||
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DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:
Metastatic disease
Not amenable to curative surgery
No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Brandon M. Hayes-Lattin, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239-3098 | United States |
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| Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years |
| Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years |
| Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years |
| Toxicity as measured by CTC AE v 3.0 100 days after transplantation |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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