A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636, IND # 100057), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma
PRIMARY OBJECTIVES:
I. Determine the complete and partial response rates after treatment with monoclonal
antibody SGN-30, gemcitabine, vinorelbine, and pegylated doxorubicin HCl liposome in
patients with relapsed or refractory Hodgkin's lymphoma.
II. Assess the time to progression and overall survival of patients treated with this
regimen.
III. Evaluate the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetic profile of SGN-30 when compared with GVD chemotherapy.
II. Correlate sCD30 levels with response to treatment. III. Determine the incidence of human
anti-chimeric antibodies (HACA) formation following repetitive SGN-30 dosing.
IV. Correlate Fc gamma receptor polymorphisms with the response to treatment.
OUTLINE:
Part 1 (Closed 5/18/2007): Patients receive monoclonal antibody SGN-30 IV over 2 hours,
vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin
HCl 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 IV over 6-10
minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin HCl liposome IV over 90
minutes on days 1 and 8.
**Treatment with SGN-30/placebo was stopped on 4/12/2007 due to pulmonary toxicity.**
Arm II (closed to accrual as of 12/4/07): Patients receive placebo IV over 2 hours,
vinorelbine IV over 6-10 minutes, gemcitabine IV over 30 minutes, and pegylated doxorubicin
HCl 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.
After completion of study treatment, patients are followed periodically for up to 10 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Overall response (OR) rate
For each arm, the true OR rate and 95% exact confidence interval will be estimated.
Up to 10 years
No
Kristie Blum
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02822
NCT00337194
April 2006
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |