Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004197
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2000-01-21
Brief Title:
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Previously Untreated Aggressive 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 Aggressive B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-09
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 cancer cells from dividing so they stop growing or die Vaccines may make the body build an immune response to kill cancer cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive non-Hodgkins lymphoma
PURPOSE Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive 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 aggressive 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 cyclophosphamide doxorubicin vincristine and prednisone CHOP or cyclophosphamide mitoxantrone vincristine and prednisone CNOP 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 6 courses At 2-6 months 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 followed by sargramostim GM-CSF SQ each at 2 separate sites on day 1 Patients receive GM-CSF alone on days 2-4 Vaccination repeats every 4 weeks for 4 doses followed 3 months 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
PROJECTED ACCRUAL Not specified
OUTLINE Patients receive induction chemotherapy consisting of cyclophosphamide doxorubicin vincristine and prednisone CHOP or cyclophosphamide mitoxantrone vincristine and prednisone CNOP 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 6 courses At 2-6 months 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 followed by sargramostim GM-CSF SQ each at 2 separate sites on day 1 Patients receive GM-CSF alone on days 2-4 Vaccination repeats every 4 weeks for 4 doses followed 3 months 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
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| SUMC-9902 | OTHER_GRANT | Supplemental UNMC | httpsreporternihgovquickSearchP30CA036727 |
| P30CA036727 | NIH | None | None |
| GENITOPE-9902 | OTHER_GRANT | None | None |