Kidney Cancer Clinical Trial
Official title:
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
Verified date | June 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | June 27, 2011 |
Est. primary completion date | June 27, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | NIH - Warren Grant Magnuson Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Carvallo 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. Epub 2003 Oct 9. — View Citation
Childs 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The anti-tumor effect of allogenic peripheral blood stem cell transplantation in patients with progressive metastatic renal cell carcinoma. | 5 Years | ||
Secondary | 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. | 100 Days | ||
Secondary | The relationship between donor-host chimerism and the incidence of acute and chronic GVHD. The effect of donor lymphocyte infusions on donor-host chimerism. Response rate, disease free and overall survival and mortality. | 100 days |
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