Clinical trial · Interventional
Fludarabine, Cyclophosphamide, and Alemtuzumab in Treating Patients With Recurrent or Metastatic Renal Cell Carcinoma (Kidney Cancer) Undergoing Allogeneic Stem Cell Transplantation
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues. Alemtuzumab and tacrolimus may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).
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 |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| graft-versus-tumor induction therapy | Biological | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with treatment related mortality
- timeFrame
- 100
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of recurrent or metastatic renal cell carcinoma * Failed interleukin-2 (IL-2)-based therapy OR intolerant to IL-2 * Clinically evident and followable disease * Availability of 1 of the following compatible donors: * Related HLA-identical or 1-Ag mismatched donor * Unrelated HLA-A, B, DRB1-matched donor PATIENT CHARACTERISTICS: Age * Any age Performance status * Karnofsky 70-100% Life expectancy * No concurrent illness that severely limits life expectancy Hematopoietic * Not specified Hepatic * No episode of hepatitis within the past month * No evidence of chronic active hepatitis or cirrhosis Renal * Creatinine no greater than 2 mg/dL Cardiovascular * LVEF at least 40% * No uncontrolled arrhythmias * No symptomatic cardiac disease Pulmonary * FEV\_1, FVC, and DLCO at least 50% of predicted (unless due to metastatic disease) Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
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