Status:
TERMINATED
SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anaplastic Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving SGN-30 together with combination chemotherapy works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal antibodies, suc...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of monoclonal antibody SGN-30 in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients with newly ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL)
- 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
- No rapidly progressing disease or bulky disease, defined as a mass of \> 7 cm in largest diameter
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00365274
Start Date
August 1 2006
End Date
May 1 2010
Last Update
June 2 2014
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030