Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT00337194
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2006-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
Sponsor:
National Cancer Institute (NCI)
Organization:
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 Relapsed/Refractory 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 5/18/2007): 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 12/4/07): 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-30/placebo was stopped on 4/12/2007 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 5/18/2007): 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 12/4/07): 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-30/placebo was stopped on 4/12/2007 due to pulmonary toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02822 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CALGB-50502 | OTHER | Cancer and Leukemia Group B | View | |
| CALGB-50502 | OTHER | CTEP | View | |
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014236 | NIH | None | https://reporter.nih.gov/quic… | View |