Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118274
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2005-07-08
Brief Title:
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II Stage III or Stage IV Melanoma
Sponsor:
Craig L Slingluff Jr
Organization:
University of Virginia
Study Overview
Official Title:
A Multicenter Trial to Evaluate the Effects of Administration of Cyclophosphamide and Melanoma-Derived Helper Peptides on the Immunogenicity of a Class I MHC-Restricted Peptide-Based Vaccine in Participants With Resected Melanoma
Status:
COMPLETED
Status Verified Date:
2021-03
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 made from peptides may help the body build an effective immune response to kill tumor cells Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Cyclophosphamide may also stimulate the immune system in different ways and stop tumor cells from growing Giving vaccine therapy together with cyclophosphamide after surgery may cause a stronger immune response to kill any remaining tumor cells It may also prevent or delay the recurrence of melanoma
PURPOSE This randomized phase III trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II stage III or stage IV melanoma
PURPOSE This randomized phase III trial is studying the side effects of vaccine therapy when given with or without cyclophosphamide and to see how well they work in treating patients who have undergone surgery for stage II stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides MP and multi-epitope melanoma helper peptides MHP emulsified in Montanide ISA-51 in patients with resected stage IIB-IV melanoma
Determine the safety of administering cyclophosphamide before vaccination in these patients
Compare the magnitude of immune response against vaccination comprising MP in combination with either MHP or tetanus toxoid helper peptide TET emulsified in Montanide ISA-51 with vs without cyclophosphamide in these patients
Secondary
Compare the response rate and persistence of immune responses in patients treated with these regimens
Compare the magnitude of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients
Compare the response rate and persistence of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients
Determine the delayed-type hypersensitivity response to the peptide components of these vaccines in these patients
Compare preliminarily disease-free survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to HLA-type HLA-A1 positive vs HLA-A2 positive HLA-A1 negative or -A3 negative vs HLA-A3 positive or -A1 negative and participating center University of Virginia UVA vs non-UVA Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive vaccine comprising multi-epitope melanoma peptides MP and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally ID and subcutaneously SC on days 1 8 15 29 36 43 85 183 274 and 365
Arm II Patients receive cyclophosphamide IV over 30-60 minutes on day -4 Patients then receive vaccine as in arm I
Arm III Patients receive vaccine comprising MP and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 ID and SC on days 1 8 15 29 36 43 85 183 274 and 365
Arm IV Patients receive cyclophosphamide as in arm II Patients then receive vaccine as in arm III
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 173 patients will be accrued for this study within 2 years
Primary
Determine the safety of adjuvant vaccine therapy comprising multi-epitope melanoma peptides MP and multi-epitope melanoma helper peptides MHP emulsified in Montanide ISA-51 in patients with resected stage IIB-IV melanoma
Determine the safety of administering cyclophosphamide before vaccination in these patients
Compare the magnitude of immune response against vaccination comprising MP in combination with either MHP or tetanus toxoid helper peptide TET emulsified in Montanide ISA-51 with vs without cyclophosphamide in these patients
Secondary
Compare the response rate and persistence of immune responses in patients treated with these regimens
Compare the magnitude of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients
Compare the response rate and persistence of immune response against vaccination comprising TET or MHP with vs without cyclophosphamide in these patients
Determine the delayed-type hypersensitivity response to the peptide components of these vaccines in these patients
Compare preliminarily disease-free survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to HLA-type HLA-A1 positive vs HLA-A2 positive HLA-A1 negative or -A3 negative vs HLA-A3 positive or -A1 negative and participating center University of Virginia UVA vs non-UVA Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive vaccine comprising multi-epitope melanoma peptides MP and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally ID and subcutaneously SC on days 1 8 15 29 36 43 85 183 274 and 365
Arm II Patients receive cyclophosphamide IV over 30-60 minutes on day -4 Patients then receive vaccine as in arm I
Arm III Patients receive vaccine comprising MP and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 ID and SC on days 1 8 15 29 36 43 85 183 274 and 365
Arm IV Patients receive cyclophosphamide as in arm II Patients then receive vaccine as in arm III
Treatment in all arms continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 173 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| MDA-2005-0070 | None | None | None |
| UVACC-34104 | None | None | None |
| UVACC-MEL-44 | None | None | None |
| UVACC-GCRC-CLS013 | None | None | None |
| UVACC-HITC-02620 | None | None | None |