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Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery Clinical research trials and Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery. Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery clinical trial. Test subjects typically receive the most effective healthcare possible for their Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery  Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
For Condition: stage 2 melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Southern California
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase / gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.
Details: OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprised of tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF). PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprised of tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage IIA or stage IIB resectable cutaneous melanoma rendered disease free - Clinically uninvolved lymph nodes by physical examination OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively - No evidence of metastatic disease within 28 days prior to definitive surgery - HLA-A2 positive --Prior/Concurrent Therapy-- - At least 1 month since prior adjuvant therapy or any other therapy for cancer - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: No concurrent steroid therapy - Radiotherapy: At least 1 month since prior radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Hematopoietic: No coagulation disorders; No significant hematologic abnormality - Hepatic: Bilirubin no greater than 2.0 mg/dL; No significant liver abnormality - Renal: Creatinine no greater than 2.0 mg/dL; No significant kidney abnormality - Cardiovascular: No major medical illness of the cardiovascular system - Pulmonary: No major medical illness of the respiratory system - Other: No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF); No major systemic infections; Not pregnant or nursing; HIV negative; Hepatitis B surface antigen negative; Hepatitis C antibody negative; No prior uveitis or autoimmune inflammatory eye disease; No active autoimmune disease; No other malignancy within past 5 years
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Study Chair, University of Southern California
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Additional Information:
Study ID Numbers: CDR0000066176; LAC-USC-10M971,NCI-T97-0100,LAC-USC-FDR001101
Study Start Date: March 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003274
Other Stage 2 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
2. Vaccine Therapy in Treating Patients With Melanoma
3. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
4. Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma
5. Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
Related Studies:
Other stage 2 melanoma Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
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