Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004198
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2000-01-21
Brief Title:
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Indolent B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-12
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Vaccines may make the body build an immune response to kill tumor cells Sargramostim may stimulate a persons immune system and help to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the ability of recombinant idiotype immunotherapy to stimulate a specific immune response against the B cell idiotype of the malignant clone that constitutes the tumor in patients with previously untreated stage III or IV indolent non-Hodgkins lymphoma II Determine the safety and toxicity of this treatment regimen using Genitope Corporations molecular rescue technology in this patient population
OUTLINE Patients receive induction chemotherapy consisting of oral cyclophosphamide vincristine and prednisone CVP Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 10 courses Patients not achieving adequate response receive up to 6 courses of alternate chemotherapy consisting of cyclophosphamide doxorubicin vincristine and prednisone At 3 months or up to 1 year following completion of chemotherapy patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously SQ at 2 sites immediately followed by sargramostim GM-CSF SQ on day 1 Patients receive GM-CSF alone on days 2-4 Vaccination repeats every 4 weeks for 4 doses followed 12 weeks later by the fifth and final dose Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter until disease progression
OUTLINE Patients receive induction chemotherapy consisting of oral cyclophosphamide vincristine and prednisone CVP Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 10 courses Patients not achieving adequate response receive up to 6 courses of alternate chemotherapy consisting of cyclophosphamide doxorubicin vincristine and prednisone At 3 months or up to 1 year following completion of chemotherapy patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously SQ at 2 sites immediately followed by sargramostim GM-CSF SQ on day 1 Patients receive GM-CSF alone on days 2-4 Vaccination repeats every 4 weeks for 4 doses followed 12 weeks later by the fifth and final dose Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter until disease progression
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 |
|---|---|---|---|
| GENITOPE-9901 | OTHER_GRANT | Genitope Corporation | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |