Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002715
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Hodgkins Lymphoma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Phase II Pilot Study of Short Term 12 Week Combination Chemotherapy Stanford V in Unfavorable Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2020-08
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the feasibility of short term chemotherapy with the Stanford V regimen mechlorethamine doxorubicin vinblastine prednisone vincristine bleomycin and etoposide followed by as indicated consolidative radiotherapy in patients with stage IIB IIIA IIIB or IV Hodgkins lymphoma
Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients
Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients
Determine the acute toxicity associated with this treatment
Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients
OUTLINE All patients are treated on Regimen A with the Stanford V Regimen those with initial bulky residual or splenic disease who achieve a CRPR proceed to Regimen B
Regimen A Patients receive mechlorethamine IV on weeks 1 5 and 9 doxorubicin and vinblastine IV on weeks 1 3 5 7 9 and 11 vincristine and bleomycin IV on weeks 2 4 6 8 10 and 12 etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3 7 and 11 and prednisone orally every other day on days 1-84 Treatment continues for 8-12 weeks depending on response in the absence of disease progression or unacceptable toxicity
Regimen B Patients begin radiotherapy 2-4 weeks after completion of Regimen A Patients receive radiotherapy to lungs pleura and other extralymphatic sites for approximately 5 weeks
Patients are followed for survival
PROJECTED ACCRUAL A total of 50 patients will be entered if at least 16 of the first 22 patients respond As of 0396 it is expected that a total of 45 patients each with stage IIIIV disease and 40 with unfavorable stage II disease will be accrued
Determine the feasibility of short term chemotherapy with the Stanford V regimen mechlorethamine doxorubicin vinblastine prednisone vincristine bleomycin and etoposide followed by as indicated consolidative radiotherapy in patients with stage IIB IIIA IIIB or IV Hodgkins lymphoma
Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients
Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients
Determine the acute toxicity associated with this treatment
Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients
OUTLINE All patients are treated on Regimen A with the Stanford V Regimen those with initial bulky residual or splenic disease who achieve a CRPR proceed to Regimen B
Regimen A Patients receive mechlorethamine IV on weeks 1 5 and 9 doxorubicin and vinblastine IV on weeks 1 3 5 7 9 and 11 vincristine and bleomycin IV on weeks 2 4 6 8 10 and 12 etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3 7 and 11 and prednisone orally every other day on days 1-84 Treatment continues for 8-12 weeks depending on response in the absence of disease progression or unacceptable toxicity
Regimen B Patients begin radiotherapy 2-4 weeks after completion of Regimen A Patients receive radiotherapy to lungs pleura and other extralymphatic sites for approximately 5 weeks
Patients are followed for survival
PROJECTED ACCRUAL A total of 50 patients will be entered if at least 16 of the first 22 patients respond As of 0396 it is expected that a total of 45 patients each with stage IIIIV disease and 40 with unfavorable stage II disease will be accrued
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-H96-0806 | OTHER | Old NCI | None |
| SUMC-G2G3 | OTHER | None | None |
| CDR0000064551 | OTHER | None | None |
| SQL 76234 | OTHER | None | None |