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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00026520
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV malignant melanoma
* Surgically incurable disease
* Measurable or evaluable disease
* No brain metastases by CT scan or MRI
* Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy
* Must have received 1, and only 1, prior systemic therapy for metastatic disease
* Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy
PATIENT CHARACTERISTICS:
Age:
* Adult
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic:
* SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)
* Bilirubin no greater than ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study
* HIV negative
* No AIDS or HIV-1-associated complex
* No other serious illness
* No serious active infections
* No sensory neuropathy greater than grade 1
* No prior seizures or concurrent potential risk factors for the development of seizures
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered
* No concurrent filgrastim (G-CSF)
* No other concurrent biologic therapy
Chemotherapy:
* See Disease Characteristics
* At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered
* No concurrent hormonal therapy
* No concurrent systemic steroids (including creams)
Radiotherapy:
* See Disease Characteristics
* At least 21 days since prior radiotherapy and recovered
* Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 21 days since prior surgery for primary or metastatic disease and recovered
* No concurrent surgery
Other:
* At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered
* At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered
* No other concurrent therapy
* No other concurrent investigational drugs
* No concurrent immunosuppressive medications
* Concurrent antihistamines allowed if no alternative medication available
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00026520
Study Brief:
Protocol Section:
NCT00026520