Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004104
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
1999-12-10
Brief Title:
Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Trial of the Effects of Interferon Alfa-2b on the Immunogenicity of a Polyvalent Melanoma Antigen Vaccine in Patients With Stage III Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines may make the body build an immune response and kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Interferon alfa-2b may interfere with the growth of tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 with or without interferon alfa-2b in treating patients who have stage III melanoma
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 with or without interferon alfa-2b in treating patients who have stage III melanoma
Detailed Description:
OBJECTIVES I Determine the effect of interferon alfa-2b on the potentiation of antimelanoma antibodies and cellular immune responses induced by immunization to a polyvalent melanoma vaccine and interleukin-2 in patients with stage III malignant melanoma II Determine the optimal dose of interferon that will maximally stimulate these responses in these patients III Determine the toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are randomized into a vaccine treated control arm or to receive one of two doses of interferon alfa-2b plus vaccine All patients receive polyvalent melanoma vaccine incorporated into interleukin-2 liposomes The vaccine is administered intradermally every 2 weeks for 8 weeks monthly for 3 months and then every 3 months for a total of 2 years or until disease progression Patients assigned to arms II or III also receive interferon alfa-2b subcutaneously at one of two doses three times a week for 2 years Patients are followed for survival
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 18 months
OUTLINE This is a randomized study Patients are randomized into a vaccine treated control arm or to receive one of two doses of interferon alfa-2b plus vaccine All patients receive polyvalent melanoma vaccine incorporated into interleukin-2 liposomes The vaccine is administered intradermally every 2 weeks for 8 weeks monthly for 3 months and then every 3 months for a total of 2 years or until disease progression Patients assigned to arms II or III also receive interferon alfa-2b subcutaneously at one of two doses three times a week for 2 years Patients are followed for survival
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| NYU-9837 | None | None | None |
| NCI-G99-1595 | None | None | None |