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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00300612
Eligibility Criteria:
Inclusion Criteria:
* Histological diagnosis of malignant melanoma. (pathology must be reviewed by Pathology Department)
* AJCC Stage IIIC (any T, N1b, N2b, N3, M0) or Stage IV (any T, any N, M1), metastatic, progressive, refractory, recurrent, or high risk of recurrence malignant melanoma.
* Adult patients \> or = to 18 years of age
* Measurable or non-measurable disease.
* Patient is \> or = to 4 weeks past major surgery, radiotherapy, chemotherapy. (6 weeks if treated with a nitrosureas) or biotherapy/targeted therapies and has recovered from the toxicity of prior treatment to \< or = to Grade 1, exclusive of alopecia or fatigue.
* Hemoglobin \> or = to 10.0 gm/dL, absolute granulocyte count \> or = to 1500/ mm3,platelets \> or = to 100,000/ mm3, absolute lymphocyte count \> or = to 475/ mm3.
* Total Bilirubin \< or = to 1.5 ULN (mg/dL), ALT (SGPT) and AST (SGOT) \< or = to 2.5 x ULN.
* Serum creatinine \< or = to 1.5 x ULN, or creatinine clearance \> or = to 50 mL/min.
* Serum albumin \> or = to 3.0 gm/dL.
* ECOG performance status \< or = to 2.
* All On-Study Test results are \< or = to Grade I toxicity for patient to be eligible for study, except for serum LDH. PT, PTT must be \< or = to 1.5 x ULN except for patients who are on therapeutic anticoagulant therapy.
* Negative serologies for Hepatitis B, Hepatitis C, and HIV
* Ability to give informed consent and express a willingness to meet all the expected requirements of the protocol including using contraception as outlined in the consent form.
* Expected survival \> 6 months. NOTE: Prior therapy for melanoma may include surgery, radiation therapy, immunotherapy including interleukins and interferon, and/or \< or = to 2 different chemotherapy regimens and other experimental therapies.
Exclusion Criteria:
* Subject has an active CNS metastases or carcinomatous meningitis. Subjects with CNS lesions that have been treated and show no evidence of progression on CT/MRI for \> or = to 3 months are eligible.
* Hypercalcemia \> 2.9 mmol/L, unresponsive to standard therapy (IV hydration, diuretics calcitonin and/or bisphosphate therapy)
* Subject is any of the following: HIV positive, history or hepatitis C virus infection, acute or chronic active hepatitis B virus infection (HbsAg positive).
* Subject has had splenectomy.
* Subject has had other malignancy within five years, and probability of recurrence of prior malignancy is \>5%. (if less than 5% subject is eligible) SEE NOTE1
* Subject has history of organ transplant or currently taking active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
* Subject is currently receiving systemic corticosteroid therapy for any reason. SEE NOTE2
* Subject has significant or uncontrolled congestive heart failure, myocardial infarction or significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
* Subject has an active infection or antibiotics within 1-week prior to study,including unexplained fever (temp \> 38.1C)
* Subject has an autoimmune disease (systemic lupus erythematosis, active rheumatoid arthritis, etc.) with the exception of vitiligo. SEE NOTE3.
* Subject has a serious medical condition that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis)
* Subject has any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with an aspect of the study.
* Subject has a known allergy to a component of the alpha(1,3)galactosyltransferase tumor vaccine or cell lines from which it is derived.
* Subject is pregnant or nursing.
NOTE1: Subjects curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or subjects with a history of malignant tumor in the past that has been disease free for at least five years are also eligible for this study.
NOTE2: Subject's receiving inhaled or topical corticosteroids are eligible. Subjects who require systemic corticosteroid therapy after beginning vaccination will be removed from the study.
NOTE3: Subjects with a remote history of asthma or mild active asthma are eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00300612
Study Brief:
Protocol Section:
NCT00300612