Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005628
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-02
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent Soft Tissue Sarcoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex HSPPC-96
Status:
COMPLETED
Status Verified Date:
2013-06
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 to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the efficacy of autologous tumor cell-derived heat shock protein peptide vaccine in terms of the rate of complete and partial response and time to progression in patients with recurrent soft tissue sarcoma II Determine the safety and tolerability of this treatment regimen in this patient population III Determine the anti-tumor response to this treatment regimen in these patients
OUTLINE At approximately 5 weeks after surgery patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
OUTLINE At approximately 5 weeks after surgery patients receive autologous tumor cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks Patients receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of disease progression or unacceptable toxicity Patients with improving or stable disease or without recurrence continue on therapy for up to 1 year
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| NCI-H00-0052 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067781 | REGISTRY | None | None |