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 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT00086866
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed cutaneous melanoma
* Unresectable stage III OR stage IV M1a disease
* Documented progressive disease within the past 12 weeks
* Measurable disease
* Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery
* Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay)
* No visceral metastases within the past 56 days by imaging
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ lower limit of normal (LLN)
* WBC ≥ LLN
* Lymphocyte count ≥ LLN
* Platelet count ≥ LLN
* No bleeding disorders
Hepatic
* Bilirubin ≤ upper limit of normal (ULN)
* Lactic dehydrogenase ≤ ULN
* AST and ALT ≤ 2 times ULN
* PT and aPTT normal
* Hepatitis B surface antigen negative (antibody test may be positive)
* Hepatitis C antibody negative
Renal
* Creatinine ≤ ULN
Cardiovascular
* No clinically significant heart disease (CTC grade III or IV)
Immunologic
* No autoimmune disease (vitiligo allowed)
* No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens
* No immunodeficiency
* No active infection requiring antibiotic therapy
* HIV negative
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No other serious acute or chronic illness requiring concurrent medications
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 8 weeks since prior adjuvant vaccine therapy
* No prior vaccine therapy containing a MAGE-3 antigen
* No prior vaccine therapy for metastatic melanoma
* No concurrent immunomodulating agents (e.g., BCG)
Chemotherapy
* No prior systemic chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* No concurrent corticosteroids
* Concurrent prednisone or equivalent allowed provided the dose is ≤ 40 mg/day and treatment duration is for no more than 3 weeks
* Concurrent inhaled and topical steroids are allowed
Radiotherapy
* No prior radiotherapy to the spleen
* No concurrent radiotherapy to \> 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions)
* Concurrent local low-dose (≤ 20 Grays) radiotherapy allowed
Surgery
* Recovered from prior surgery or biopsy
* No prior organ allograft
* No prior splenectomy
* Concurrent surgery to a limited number of lesions allowed for patients with a complete response, partial response, or stable disease after at least 3 courses of study therapy
Other
* No prior systemic anticancer therapy
* More than 4 weeks since prior isolated limb perfusion therapy
* No other concurrent anticancer therapy
* No other concurrent immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00086866
Study Brief:
Protocol Section:
NCT00086866