SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
NCT ID: NCT00365274
Last Updated: 2014-06-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2006-08-31
2010-05-31
Brief Summary
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Detailed Description
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I. Determine the efficacy of monoclonal antibody SGN-30 in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients with newly diagnosed anaplastic large cell lymphoma (ALCL).
II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.
SECONDARY OBJECTIVES:
I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
II. Determine the response duration in patients treated with this regimen.
III. Correlate response with pretreatment serum CD30 levels.
IV. Determine response to single-agent monoclonal antibody SGN-30.
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large cell kinase (ALK) status (positive vs negative).
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over 2 hours once weekly for 3 weeks.
Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SGN-30 + Combination Chemotherapy
Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously(IV) over 2 hours once weekly for 3 weeks.
SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.
Cyclophosphamide
Given IV 750 mg/m\^2 day 1
Doxorubicin hydrochloride
Given 50 mg/m\^2 IV day 1
vincristine sulfate
Given 1.4 mg/m\^2 IV
prednisone
100 mg orally daily days 1 - 5
SGN-30
12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Interventions
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Cyclophosphamide
Given IV 750 mg/m\^2 day 1
Doxorubicin hydrochloride
Given 50 mg/m\^2 IV day 1
vincristine sulfate
Given 1.4 mg/m\^2 IV
prednisone
100 mg orally daily days 1 - 5
SGN-30
12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tissue available for the determination of anaplastic large cell kinase (ALK) status \[t(2;5), ALK-NPM translocation\] prior to study entry
* Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment
* Measurable disease, defined as \>= 1 lesion that can be accurately measured in \>= 1 dimension (longest diameter to be recorded) as \>= 20 mm by conventional techniques or as \>= 10 mm by spiral CT scan
* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
* White Blood Count (WBC) \>= 3,000/mm³
* Absolute neutrophil count \>= 1,500/mm³
* Platelet count \>= 100,000/mm³ (unless due to lymphoma \[i.e., splenomegaly and/or bone marrow involvement\])
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* AST or ALT =\< 2.5 times ULN
* Creatinine =\< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance \>=60 mL/min
* Left ventricular ejection fraction (LVEF) \>= 50%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Exclusion Criteria
* No primary cutaneous ALCL
* No known brain metastases
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30
* No uncontrolled intercurrent illness, including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situations that would preclude study compliance
* No prior or other concurrent malignancy with \< 90% probability of survival at 5 years
* No other concurrent anticancer agents or therapies
* No prior chemotherapy for ALCL
* No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Michelle Fanale, MD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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The University of Texas MD Anderson Cancer Center official website
Other Identifiers
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