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Adesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase III Randomized Study of High-Dose Aldesleukin With or Without gp100 Antigen in Patients With Locally Advanced or Metastatic Cutaneous Melanoma
Basic Trial Information
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Sponsor
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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NCI, Pharmaceutical / Industry
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CCCGHS-NCI-T98-0085
NCI-T98-0085, NCI-99-C-0051B, T98-0085, NCT00019682
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Trial Description Purpose: Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating metastatic melanoma.
Randomized phase III trial to compare the effectiveness of aldesleukin with or without vaccine therapy in treating patients with stage III or stage IV melanoma. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Patients will be randomly assigned to one of two groups. Patients in group one will receive an infusion of aldesleukin every 8 hours for up to 12 doses. Patients in group two will receive an injection of the gp100 vaccine plus aldesleukin as in group one. Treatment may be repeated every 3 weeks for up to 14 courses. Quality of life will be assessed before and after the first course of aldesleukin. Patients will receive follow-up evaluations every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and once a year thereafter.
Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site.
Trial Contact Information
Trial Lead Organizations Center for Cancer Care at Goshen General Hospital | | | | Douglas Schwartzentruber, MD, Protocol chair | | | Ph: 574-535-2893; 866-711-2888 |
| | | Daniel Bruetman, MD, Protocol co-chair | | | |
Trial Sites
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| U.S.A. |
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| Alabama |
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Birmingham |
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| | | | | | | | | Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham |
| | | Clinical Trials Office - Lurleen Wallace Comprehensive Cancer | |
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| Arizona |
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Phoenix |
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| | | | Mayo Clinic Hospital |
| | | Barbara Pockaj, MD | | Ph: | 480-301-6551 | | 800-446-2279 |
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| | Email:
pockaj.barbara@mayo.edu |
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| California |
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Riverside |
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| | | | Kaiser Permanente Medical Center - Riverside |
| | | Fawaz Gailani, MD, FACP | |
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| Colorado |
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Aurora |
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| | | | University of Colorado Cancer Center at UC Health Sciences Center |
| | | Clinical Trials Office - University of Colorado Cancer Center | |
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| Florida |
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Lakeland |
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| | | | Lakeland Regional Cancer Center at Lakeland Regional Medical Center |
| | | Douglas Reintgen, MD | | Ph: | 863-603-6565 | | 866-823-4405 |
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| Illinois |
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Chicago |
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| | | | Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| | | Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| | Email:
cancer@northwestern.edu |
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Park Ridge |
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| | | Advocate Lutheran General Cancer Care Center |
| | | Clinical Trials Office - Advocate Lutheran General Cancer Care Center | |
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| Indiana |
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Goshen |
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| | | | Center for Cancer Care at Goshen General Hospital |
| | | Clinical Trials Office - Center for Cancer Care at Goshen General Hospital | |
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| Kentucky |
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Louisville |
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| | | | James Graham Brown Cancer Center at University of Louisville |
| | | Donald Miller, MD, PhD | | Ph: | 502-562-4790 | | 866-530-5516 |
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| | Email:
donaldmi@ulh.org |
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| North Carolina |
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Charlotte |
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| | | | Blumenthal Cancer Center at Carolinas Medical Center |
| | | Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center | |
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| Ohio |
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Cincinnati |
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| | | | Christ Hospital Cancer Center |
| | | Philip Leming, MD | |
| | Email:
pianoblues@aol.com |
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Columbus |
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| | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | | Clinical Trials Office - OSU Comprehensive Cancer Center | |
| | Email:
osu@emergingmed.com |
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| Pennsylvania |
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Bethlehem |
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| | | | St. Luke's Cancer Network at St. Luke's Hospital |
| | | Lee Riley, MD, PhD, FACS | |
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| Texas |
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Houston |
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| | | | M. D. Anderson Cancer Center at University of Texas |
| | | Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas | |
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| Wisconsin |
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Milwaukee |
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| | | | Medical Consultants, Limited |
| | | Jonathan S. Treisman, MD | |
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| Registry Information | | | Official Title | | A Phase III Multi-Institutional Randomized Study of Immunization with the GP100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients with Metastatic Melanoma | | | Trial Start Date | | 2000-06-14 | | | Trial Completion Date | | 2002-05-08 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00019682 | | | Date Submitted to PDQ | | 1999-03-10 | | | Information Last Verified | | 2008-11-30 |
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