Vaccine Therapy for Patients With Stage IV Melanoma

• ClinicalTrials.gov Identifier: NCT00052156
• Recruitment Status: Unknown
• First Posted: January 24, 2003
• Last Update Posted: June 24, 2005
• Sponsor: CancerVax Corporation
• Information provided by: CancerVax Corporation

Tracking Information

• First Submitted Date: January 23, 2003
• First Posted Date: January 24, 2003
• Last Update Posted Date: June 24, 2005
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vaccine Therapy for Patients With Stage IV Melanoma
• Official Title: A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
• Brief Summary: This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Malignant Melanoma
• Intervention: Biological: CancerVax vaccine (CANVAXIN)
• Study Arms: Not Provided

Publications *

• Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.
• Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: June 23, 2005): 670
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

• Must have Stage IV melanoma
• Must have had all clinically-detectable disease surgically removed
• Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
• Cannot have HIV or Hepatitis A, B, or C

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Brazil, Canada, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT00052156
• Other Study ID Numbers: CV-MMAIT-4-001; JWCI-MC-4-001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: CancerVax Corporation
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CancerVax Corporation
• Verification Date: April 2005