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Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma Clinical research trials and Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma. Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma  Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma
Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma
For Condition: stage 3 melanoma
Status: No longer recruiting
Sponsor(s): AVAX Technologies ,
Synopsis: RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.
Details: OBJECTIVES: I. Compare the relapse free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population. PROTOCOL OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed melanoma metastatic to regional lymph nodes with a clinically palpable mass - Must have undergone complete resection of tumor, measuring at least 2 cm in diameter, within the past 6 weeks - No distant metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 6 weeks since prior cytotoxic drugs (except for isolated limb perfusion) - Endocrine therapy: No concurrent systemic corticosteroids - Radiotherapy: At least 6 months since prior radiotherapy - Surgery: See Disease Characteristics - Other: At least 30 days since prior investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: At least 6 months - Hematopoietic: Hematocrit at least 30%; WBC at least 3,000/mm3 - Hepatic: Hepatitis B and C negative - Renal: Not specified - Other: Not pregnant or nursing; No active serious infection; No active autoimmune disease; HIV negative; At least 5 years since prior malignancy except squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder carcinoma, early stage prostate cancer, or noninvasive melanoma; No active severe depression or psychiatric disorder with psychotic symptoms; No uncontrolled thyroid abnormalities
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ErnestYankee, Study Chair, AVAX Technologies
Columbia - HCA Cancer Research Network
Miami, Florida, 33180
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
United States
Georgia Cancer Specialists
Decatur, Georgia, 30033
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Jersey Shore Cancer Center
Neptune, New Jersey, 07753
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
Midwest Oncology Consortium
Kansas City, Missouri, 64111
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Additional Information:
Study ID Numbers: CDR0000066824; AVAX-A/100/0101
Study Start Date: December 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003715
Other Stage 3 Melanoma Studies:
1. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
2. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
3. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
4. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
5. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other stage 3 melanoma Clinical Trials
Other Kentucky Clinical Trials
Other Louisville Clinical Trials
Vaccine Therapy Compared With Interferon alfa in Treating Patients With Stage III Melanoma
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