SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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, such as SGN-30, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving SGN-30 together with combination chemotherapy may kill more cancer cells

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Brentuximab Vedotin; Cyclophosphamide; Doxorubicin; Immunoglobulins; Liposomal doxorubicin; Molecular Mechanisms of Pharmacological Action; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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