Clinical trial · Interventional
Peripheral Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer
A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy
- 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: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well peripheral 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLA Matched Peripheral BLood Stem Cells | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- The target for progenitor cell is \>=5 x 106 CD 34/kg.
- interventionNames
- Other: HLA Matched Peripheral BLood Stem Cells
Primary outcomes (1)
- measure
- The anti-tumor effect of allogenic peripheral blood stem cell transplantation in patients with progressive metastatic renal cell carcinoma.
- timeFrame
- 5 Years
Secondary outcomes (2)
- measure
- Evaluate the safety and toxicity of a nonmyeloblative, low intensity, preparative regimen followed by an HLA matched allogenic peripheral blood stem cell transplant in patients with metastatic renal cell carcinoma.
- timeFrame
- 100 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
INCLUSION CRITERIA - PATIENT: Ages 18-80 years. Biopsy proven metastatic RCC, not amenable to complete surgical resection, progressive bidimensionally evaluable clinically or radiographically. No prior treatment for RCC within 30 days. HIV negative. ECOG performance status of 1 or less. No major organ dysfunction precluding transplantation. DLCO greater than or equal to 65% predicted. Left ventricular ejection fraction greater than or equal to 40%. HLA 6/6 or 5/6 matched family related donor available. Ability to comprehend the investigational nature of the study and provide informed consent. Durable power of attorney signed. INCLUSION CRITERIA - DONOR: HLA 6/6 or 5/6 matched family related donor. Fit to receive G-CSF and give peripheral blood stem cells (normal blood counts, normotensive, no history of stroke). Ability to comprehend the investigational nature of the study and provide informed consent. Ages 18-80. EXCLUSION CRITERIA (any of the following) - PATIENT: Patient Pregnant. Age greater than 80 or less than 18 years. ECOG performance status of 2 or more. Psychiatric disorder or mental deficiency of the patient or donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT where survival is considered insufficient to assess transplant outcome (i.e. less than 3 months). DLCO less than 65% predicted. Left ventricular ejection fraction less than 40%. Serum creatinine greater than 2.5mg/dl or creatinine clearance less than 50 cc/min by 24 hour urine collection. Serum bilirubin greater than 4 mg/dl, transaminases greater than 3 x upper limit of normal. HIV positive. History of other malignancies except basal cell or squamous carcinoma of the skin. Disease which is limited and amenable to complete surgical resection. Lack of evidence for progressive disease. Disease which is not evaluable clinically or radiographically. Evidence for CNS metastatic disease. Disease involving greater than 25% of the liver radiographically. Hypercalcemia (greater than 2.5 mmol/L). EXCLUSION CRITERIA - DONOR: Donor pregnant or lactating. Donor HIV or HBsAg positive. History of malignancy within 5 years except basal cell or squamous carcinoma of the skin. Donor unfit to receive G-CSF and undergo apheresis (Uncontrolled hypertension, history of stroke, thrombocytopenia).
References
Publications (2)
- BACKGROUNDCarvallo C, Geller N, Kurlander R, Srinivasan R, Mena O, Igarashi T, Griffith LM, Linehan WM, Childs RW. Prior chemotherapy and allograft CD34+ dose impact donor engraftment following nonmyeloablative allogeneic stem cell transplantation in patients with solid tumors. Blood. 2004 Feb 15;103(4):1560-3. doi: 10.1182/blood-2003-04-1170. Epub 2003 Oct 9. PMID 14551148
- RESULTChilds R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8. doi: 10.1056/NEJM200009143431101. PMID 10984562