Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Agenus Inc.
Primary Objective:
* To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
* To determine frequency of adverse events in subjects randomized to HSPPC-96.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligibility Assessment:
(The following assessments must be obtained within three weeks prior to randomization into the study)
Medical history and physical examination (including EGOG score, evidence of immunosuppression);
CT/MRI of the chest, abdomen and pelvis;
Clinical examination;
CT/MRI of the brain;
Complete Blood Count with differential including platelets;
Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);
Renal function tests (BUN and creatinine);
Liver function tests (bilirubin, AST, ALT);
Serum pregnancy test for all women of childbearing potential.
Stage IV Melanoma (AJCC);
No prior therapy for stage IV melanoma;
No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;
Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;
No brain metastases;
ECOG score 0 or 1;
Adequate cardiac function;
Adequate hematopoietic, liver and renal function;
Female subjects of child-bearing potential must agree to use contraception during the study
Signed written informed consent.
You may not be if
Mucosal or ocular melanomas;
Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);
Prior splenectomy;
Uncontrolled infection or other serious medical illnesses;
Women who are pregnant or breast-feeding;
Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.
