Last Verified: | May/31/2020 |
First Submitted: | October/31/1999 |
Estimated Enrollment Submitted: | January/25/2003 |
First Posted: | January/26/2003 |
Last Update Submitted: | June/17/2020 |
Last Update Posted: | June/18/2020 |
Actual Study Start Date: | February/8/1998 |
Estimated Primary Completion Date: | June/26/2011 |
Estimated Study Completion Date: | June/26/2011 |
Study Type: | Interventional |
Allocation: | N/A |
: | patients with progressive metastatic renal cell carcinoma. |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: 1 The target for progenitor cell is >=5 x 106 CD 34/kg. | Other: 1 Cell Product |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | 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). |