Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-03 @ 2:06 AM
Study NCT ID:
NCT00616720
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2008-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-05
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: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
Detailed Description:
OBJECTIVES:
Primary
* To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
* To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.
Secondary
* To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
* To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
* To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.
OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment (post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are randomized to 1 of 2 arms.
In both arms, patients undergo apheresis for collection of peripheral blood mononuclear cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by loading DC with immunoglobulin idiotype prepared from the patient's serum.
* Arm I: Patients receive interferon-gamma subcutaneously (SC) once daily on days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 IV over 30-minutes on days 2, 16, and 30.
* Arm II: Patients receive aldesleukin SC once daily days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 as in arm I.
In both arms, treatment continues in the absence of disease progression.
Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype protein; and CTL and T-helper response by flow cytometry.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
Primary
* To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
* To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.
Secondary
* To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
* To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
* To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.
OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment (post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are randomized to 1 of 2 arms.
In both arms, patients undergo apheresis for collection of peripheral blood mononuclear cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by loading DC with immunoglobulin idiotype prepared from the patient's serum.
* Arm I: Patients receive interferon-gamma subcutaneously (SC) once daily on days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 IV over 30-minutes on days 2, 16, and 30.
* Arm II: Patients receive aldesleukin SC once daily days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 as in arm I.
In both arms, treatment continues in the absence of disease progression.
Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype protein; and CTL and T-helper response by flow cytometry.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| 998003 | OTHER | Mayo Clinic Cancer Center | View | |
| 789-99 | OTHER | Mayo Clinic IRB | View |