Clinical trial · Interventional
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
Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a lack of a referal base, study was terminated.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate (complete and partial response) at 6 and 12 months after transplantation
Secondary outcomes (6)
- measure
- Severity of graft-vs-host-disease by Glucksburg Scale after transplantation for up to 5 years
- measure
- Incidence of graft rejection based on donor chimerims after transplantation for up to 5 years
- measure
- Non-relapse mortality as assessed by Kaplan-Meier after transplantation for up to 5 years
- measure
- Disease-free survival as assessed by Kaplan-Meier after transplantation for up to 5 years
- measure
- Overall survival as assessed by Kaplan-Meier after transplantation for up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available