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Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma Clinical research trials and Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma. Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma clinical trial. Subjects frequently get the best healthcare possible for their Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma  Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
For Condition: Malignant Melanoma
Status: Recruiting
Sponsor(s): Antigenics ,
Synopsis: The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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. Inclusion Criteria: - 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. Exclusion Criteria: - 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.
Total Enrollment: 350
Location and Contact Information:
Additional Information:
Study ID Numbers: C-100-21;
Study Start Date: March 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039000
Other Malignant Melanoma Studies:
1. Vaccine Therapy for Patients with Stage IV Melanoma
2. Vaccine Therapy for Patients with Stage III Melanoma
3. Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
4. Phase I Study of gp75 Vaccine in Patients with Stage III and IV Melanoma
5. Phase II Trial of Allovectin-7® for Metastatic Melanoma
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Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus IL-2/DTIC for Stage IV Melanoma
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