Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT00056095
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00056095
Study Brief:
Protocol Section:
NCT00056095