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
18 Years
N/A
Both
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma
Trial Information
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.
Inclusion Criteria:
- Histologically confirmed CD30+ classical Hodgkin's lymphoma, including the following
subtypes:
- Nodular sclerosis
- Lymphocyte-depleted
- Lymphocyte-rich
- Mixed cellularity
- Original diagnostic specimen or specimen from relapse required Core needle biopsy
allowed provided there is adequate tissue for primary diagnosis and immunophenotyping
- Bone marrow biopsy allowed provided nodal biopsy is available
- No fine needle aspirates
- Relapsed or refractory disease after >= 1 prior therapy
- Measurable disease, defined as any lesion that can be accurately measured in >= 1
dimension as >= 10 mm
- Nonmeasurable or evaluable disease allowed provided measurable disease is
present; nonmeasurable disease includes any of the following:
- Bone lesions
- Bone marrow involvement
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- No nodular lymphocyte-predominant Hodgkin's lymphoma
- ECOG performance status 0-2
- Absolute neutrophil count >= 1,200/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 2.0 mg/dL
- Bilirubin =< 2.0 mg/dL (in the absence of Gilbert's disease)
- AST =< 2.0 times upper limit of normal
- LVEF >= 45% by MUGA or ECHO
- DLCO >= 50%
- Not pregnant
- Negative pregnancy test
- No nursing during and for 6 months after completion of study treatment
- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment
- No uncontrolled angina
- No myocardial infarction within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- At least 3 weeks since prior chemotherapy or radiotherapy and recovered
- Prior autologous, allogeneic, or unrelated stem cell transplantation allowed
- No prior anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated doxorubicin HCl
liposome
- No other concurrent chemotherapy
- No concurrent steroids or hormones
- Steroids given for adrenal failure or hormones administered for
nondisease-related conditions (e.g., insulin for diabetes) allowed
- No concurrent dexamethasone, except as needed to treat monoclonal antibody SGN-30 or
pegylated doxorubicin HCl liposome infusion reactions, or as an anti-emetic on the
day of chemotherapy
- No concurrent palliative radiotherapy
- No concurrent pegfilgrastim
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall response (OR) rate
Outcome Description:
For each arm, the true OR rate and 95% exact confidence interval will be estimated.
Outcome Time Frame:
Up to 10 years
Safety Issue:
No
Principal Investigator
Kristie Blum
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer and Leukemia Group B
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02822
NCT ID:
NCT00337194
Start Date:
April 2006
Completion Date:
Related Keywords:
- Adult Lymphocyte Depletion Hodgkin Lymphoma
- Adult Mixed Cellularity Hodgkin Lymphoma
- Adult Nodular Sclerosis Hodgkin Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Hodgkin Disease
- Lymphoma
- Sclerosis
Name | Location |
|---|---|
| Cancer and Leukemia Group B | Chicago, Illinois 60606 |
