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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00006233
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV melanoma
* Partial response, minor response, or stable disease after no more than 2 regimens of chemotherapy, immunotherapy, or chemoimmunotherapy
* Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging
* HLA genotypically identical sibling donor available
* Not an identical twin
* Age 12 to 74
* No ocular melanoma
* No active or untreated brain metastases or transmural gastrointestinal metastases
PATIENT CHARACTERISTICS:
Age:
* 18 to 64
Performance status:
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT and SGPT less than 2 times ULN
Renal:
* Creatinine clearance at least 40 mL/min
Cardiovascular:
* LVEF at least 40% if history of congestive heart failure
* No uncontrolled hypertension
Pulmonary:
* DLCO at least 50% of predicted
* No continuous supplementary oxygen
Other:
* Not pregnant
* Fertile patients must use effective contraception during and for 1 year after study participation
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No concurrent growth factors during mycophenolate mofetil administration
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00006233
Study Brief:
Protocol Section:
NCT00006233