Clinical trial · Interventional
Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
NCT00056095CI-TRIAL-00050285completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic 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 |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Allograft (compatible family member)
- interventionNames
- Biological: therapeutic allogeneic lymphocytes
- Drug: cyclophosphamide
- Drug: cyclosporine
- Drug: fludarabine phosphate
- Procedure: allogeneic bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
- type
- OTHER
- label
- Allograft (compatible non-family member)
- interventionNames
- Procedure: allogeneic bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (4)
- measure
- Survival rate at 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * No sarcomatoid, pure papillary, or Bellini renal cell cancer * Measurable and/or evaluable disease * Disease progression after at least 1 immunotherapy regimen for metastatic disease * Localized metastases allowed provided the following are true: * At least 3 months since prior treatment for metastases * Not considered likely to influence outcome of transplantation * No brain metastases unless treated surgically or radiologically and MRI normal * Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * Platelet count at least 100,000/mm\^3 Hepatic * Transaminases less than 1.5 times upper limit of normal (ULN)\* * Bilirubin less than 1.5 times ULN\* NOTE: \*Unless due to Gilbert's disease Renal * No renal insufficiency * Calcium less than 10.4 mg/dL * Creatinine clearance greater than 50 mL/min Cardiovascular * Ejection fraction greater than 50% Pulmonary * No DLCO that would preclude fludarabine or busulfan therapy Other * Not pregnant or nursing * Fertile patients must use effective contraception * No physical obstacle to receiving study treatment * No known autoimmune disease * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled bacterial, viral, or fungal infection * No prior or concurrent psychiatric disease * HIV negative * HTLV1 negative PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * No tolerance to fludarabine and busulfan Endocrine therapy * No concurrent corticosteroids Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.