Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019448
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2024-02
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 made from DNA may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells Combining vaccine therapy and interleukin-2 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the clinical response of patients receiving DNA gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma
II Identify the immunologic response in these patients prior to and after these treatments
III Determine the toxicity of these treatments in these patients
PROTOCOL OUTLINE Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed
Cohort I Patients receive gp100 antigen intramuscularly IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses Closed as of December 1999 Cohort II Patients receive gp100 antigen intradermally ID at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses Closed as of December 1999 Cohort III Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses If patients do not exhibit immunologic response or dose-limiting toxicity they may receive a higher dose of gp100 antigen on subsequent courses
Cohort IV If cohorts I II or III do not produce an immune response and do not experience dose-limiting toxicity patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses
Cohort V Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days 15 doses beginning within 24 hours after gp100 antigen
Patients with minor mixed or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest Patients receive a maximum of 12 courses
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL
A maximum of 65 patients will be accrued for this study within 1 year
II Identify the immunologic response in these patients prior to and after these treatments
III Determine the toxicity of these treatments in these patients
PROTOCOL OUTLINE Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed
Cohort I Patients receive gp100 antigen intramuscularly IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses Closed as of December 1999 Cohort II Patients receive gp100 antigen intradermally ID at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses Closed as of December 1999 Cohort III Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses If patients do not exhibit immunologic response or dose-limiting toxicity they may receive a higher dose of gp100 antigen on subsequent courses
Cohort IV If cohorts I II or III do not produce an immune response and do not experience dose-limiting toxicity patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses
Cohort V Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days 15 doses beginning within 24 hours after gp100 antigen
Patients with minor mixed or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest Patients receive a maximum of 12 courses
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL
A maximum of 65 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-98-C-0086 | None | None | None |