Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337194
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2006-06-13
Brief Title:
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody SGN-30 NSC 731636 in Combination With Gemcitabine Vinorelbine and Pegylated Liposomal Doxorubicin GVD for Patients With RelapsedRefractory Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-10
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:
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment Monoclonal antibodies such as SGN-30 may interfere with the ability of cancer cells to grow and spread Drugs used in chemotherapy such as gemcitabine hydrochloride vinorelbine tartrate and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors
Detailed Description:
PRIMARY OBJECTIVES
I To determine the complete and partial response rates following treatment with the anti-cluster of differentiation CD 30 antibody SGN-30 monoclonal antibody SGN-30 and gemcitabine gemcitabine hydrochloride vinorelbine vinorelbine tartrate and pegylated liposomal doxorubicin pegylated liposomal doxorubicin hydrochloride GVD in patients with relapsed or refractory Hodgkin lymphoma HL
II To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma HL
III To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL
SECONDARY OBJECTIVES
I To determine the pharmacokinetic profile of SGN-30 when combined with GVD chemotherapy
II To correlate soluble s CD30 levels with response to treatment III To determine the incidence of human anti-chimeric antibodies HACA formation following repetitive SGN-30 dosing
IV To correlate Fc gamma receptor polymorphisms with response to treatment
OUTLINE
Part 1 closed to accrual as of 5182007 Patients receive monoclonal antibody SGN-30 intravenously IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity Subsequent patients receive treatment on part 2
Part 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive monoclonal antibody SGN-30 IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8
Arm II closed to accrual as of 12407 Patients receive placebo IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8
Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE Treatment with SGN-30placebo was stopped on 4122007 due to pulmonary toxicity
After completion of study treatment patients are followed up periodically for up to 10 years
I To determine the complete and partial response rates following treatment with the anti-cluster of differentiation CD 30 antibody SGN-30 monoclonal antibody SGN-30 and gemcitabine gemcitabine hydrochloride vinorelbine vinorelbine tartrate and pegylated liposomal doxorubicin pegylated liposomal doxorubicin hydrochloride GVD in patients with relapsed or refractory Hodgkin lymphoma HL
II To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma HL
III To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL
SECONDARY OBJECTIVES
I To determine the pharmacokinetic profile of SGN-30 when combined with GVD chemotherapy
II To correlate soluble s CD30 levels with response to treatment III To determine the incidence of human anti-chimeric antibodies HACA formation following repetitive SGN-30 dosing
IV To correlate Fc gamma receptor polymorphisms with response to treatment
OUTLINE
Part 1 closed to accrual as of 5182007 Patients receive monoclonal antibody SGN-30 intravenously IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8 Treatment repeats every 21 days until 10 out of 16 patients complete 1 course in the absence of unacceptable toxicity Subsequent patients receive treatment on part 2
Part 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive monoclonal antibody SGN-30 IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8
Arm II closed to accrual as of 12407 Patients receive placebo IV over 2 hours vinorelbine tartrate IV over 6-10 minutes gemcitabine hydrochloride IV over 30 minutes and pegylated doxorubicin hydrochloride liposome IV over 90 minutes on days 1 and 8
Treatment in both arms repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
NOTE Treatment with SGN-30placebo was stopped on 4122007 due to pulmonary toxicity
After completion of study treatment patients are followed up periodically for up to 10 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 |
|---|---|---|---|
| P30CA014236 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014236 |
| NCI-2012-02822 | REGISTRY | None | None |
| CALGB-50502 | OTHER | None | None |
| CALGB-50502 | OTHER | None | None |
| U10CA031946 | NIH | None | None |