Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003715
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma
Sponsor:
AVAX Technologies
Organization:
AVAX Technologies
Study Overview
Official Title:
A Prospective Randomized Open-Label Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated recruiting or enrolling participants has halted prematurely and will not resume participants are no longer being examined or treated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons 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
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
Detailed Description:
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
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to number of metastatic lymph node sites 1 vs more than 1 number of positive lymph nodes in a single site none vs 1 or more presence of intransit metastases yes vs no and evidence of extranodal extension yes vs no 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
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to number of metastatic lymph node sites 1 vs more than 1 number of positive lymph nodes in a single site none vs 1 or more presence of intransit metastases yes vs no and evidence of extranodal extension yes vs no 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AVAX-A1000101 | None | None | None |