Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004249
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-01-28
Brief Title:
Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Immunization Using Polysialic Acid-KLH or N-Propionylated Polysialic Acid-KLH Conjugate Plus the Immunological Adjuvant QS-21 in Patients With Small Cell Lung Cancer Who Have Achieved a Major Response to Initial Therapy
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 Biological therapies such as QS21 use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have small cell lung cancer that has responded to initial therapy
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have small cell lung cancer that has responded to initial therapy
Detailed Description:
OBJECTIVES I Compare the antibody response after immunization with polysialic acid keyhole limpet hemocyanin PSA-KLH conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 in patients with small cell lung cancer II Assess the clinical toxicities resulting from these regimens and from the immune response in this patient population
OUTLINE Patients receive polysialic acid keyhole limpet hemocyanin PSA-KLH conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations Patients are followed at 2 weeks and then every 3 months for up to 1 year
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
OUTLINE Patients receive polysialic acid keyhole limpet hemocyanin PSA-KLH conjugate or N-propionylated PSA-KLH conjugate plus immunological adjuvant QS21 subcutaneously weekly on weeks 1-4 and on weeks 8 and 16 for a total of 6 vaccinations Patients are followed at 2 weeks and then every 3 months for up to 1 year
PROJECTED ACCRUAL A total of 12 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-H99-0047 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067495 | REGISTRY | None | None |