Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020462
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2001-07-11
Brief Title:
Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III Stage IV or Recurrent Follicular Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Active Specific Immunotherapy for Follicular Lymphomas With Liposomes Containing Tumor-Derived Antigen and IL-2
Status:
COMPLETED
Status Verified Date:
2008-12
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 a persons cancer cells may make the body build an immune response to kill tumor cells Combining vaccine therapy with interleukin-2 may be a more effective treatment for follicular lymphoma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have stage III stage IV or recurrent follicular lymphoma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have stage III stage IV or recurrent follicular lymphoma
Detailed Description:
OBJECTIVES
Assess the safety of immunotherapy with autologous tumor cell vaccine and interleukin-2 in patients with stage III IV or recurrent follicular lymphoma
Determine the clinical response of patients treated with this regimen
Assess the immune response of patients treated with this vaccine
OUTLINE This is a multicenter study Patients are stratified according to prior therapy no prior biologic therapy or chemotherapy for lymphoma vs prior prednisone doxorubicin cyclophosphamide and etoposide PACE chemotherapy Patients without prior therapy are further stratified according to accessibility of lymph nodes easily accessible stratum Ia vs not easily accessible stratum Ib
All patients undergo lymph node biopsy to obtain tissue for vaccine manufacture Treatment begins approximately 1 month after biopsy
Stratum Ia Patients receive autologous tumor cell vaccine and interleukin-2 IL-2 intranodally and subcutaneously SC on day 1
Stratum Ib and stratum II Patients receive autologous tumor cell vaccine and IL-2 SC on day 1
Treatment in each stratum continues every 4 weeks for a maximum of 5 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 and 4 months every 3 months for 1 year and every 6 months thereafter until relapse or progression of disease
PROJECTED ACCRUAL A total of 20 patients 10 per stratum will be accrued for this study within 15-2 years
Assess the safety of immunotherapy with autologous tumor cell vaccine and interleukin-2 in patients with stage III IV or recurrent follicular lymphoma
Determine the clinical response of patients treated with this regimen
Assess the immune response of patients treated with this vaccine
OUTLINE This is a multicenter study Patients are stratified according to prior therapy no prior biologic therapy or chemotherapy for lymphoma vs prior prednisone doxorubicin cyclophosphamide and etoposide PACE chemotherapy Patients without prior therapy are further stratified according to accessibility of lymph nodes easily accessible stratum Ia vs not easily accessible stratum Ib
All patients undergo lymph node biopsy to obtain tissue for vaccine manufacture Treatment begins approximately 1 month after biopsy
Stratum Ia Patients receive autologous tumor cell vaccine and interleukin-2 IL-2 intranodally and subcutaneously SC on day 1
Stratum Ib and stratum II Patients receive autologous tumor cell vaccine and IL-2 SC on day 1
Treatment in each stratum continues every 4 weeks for a maximum of 5 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 and 4 months every 3 months for 1 year and every 6 months thereafter until relapse or progression of disease
PROJECTED ACCRUAL A total of 20 patients 10 per stratum will be accrued for this study within 15-2 years
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-01-C-0069 | None | None | None |