Overview

This trial is active, not recruiting.

Conditions cd30-positive neoplastic cells present, recurrent hodgkin lymphoma, recurrent non-hodgkin lymphoma, refractory hodgkin lymphoma, refractory non-hodgkin lymphoma
Treatments brentuximab vedotin, laboratory biomarker analysis
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date March 2013
End date June 2015
Trial size 8 participants
Trial identifier NCT01703949, 7808, NCI-2012-01696, P30CA015704

Summary

This pilot clinical trial studies brentuximab vedotin in treating patients with CD30+ lymphoma has come base after a period of improvement or does not respond to treatment. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin ADC SGN-35
Given IV
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Overall response rate as measured by the Cheson 2007 criteria
time frame: Up to 5 weeks after completion of study treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles) or progressed while receiving brentuximab vedotin - Documented expression of CD30 on tumor cells following the last dose of brentuximab vedotin - Absolute neutrophil count (ANC) > 1,000/uL - Platelets > 50,000/uL - Serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 mL/min - Bilirubin < 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN - Measurable disease by computed tomography (CT) or similar (e.g. magnetic resonance imaging [MRI]) criteria (> 1.5 cm) - Resolution of all non-hematologic brentuximab vedotin-related adverse events (AEs) to < grade 2 - All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines - Patients must be anticipated to complete at least 2 cycles of chemotherapy on study - Expected survival if untreated of > 90 days Exclusion Criteria: - Prior transplant within 100 days - Radioimmunotherapy within 12 weeks - Known human immunodeficiency virus (HIV) or hepatitis B positivity - Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator - Eastern Cooperative Oncology Group (ECOG) performance status > 2 - Known active central nervous system (CNS) involvement - Peripheral neuropathy > grade 1 if due to brentuximab vedotin or any peripheral neuropathy > grade 2 - Intolerance to brentuximab vedotin - Concurrent use of other anti-cancer agents or experimental treatments

Additional Information

Official title A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin
Principal investigator Ajay Gopal
Description PRIMARY OBJECTIVES: I. To estimate the response rate following weekly brentuximab vedotin (1.2 mg/kg 3 of 4 weeks for up to four 28-day cycles) in patients with lack of response (< partial response [PR]) or progression following brentuximab vedotin and demonstrating persistent expression of CD30. SECONDARY OBJECTIVES: I. To monitor clinical outcome following the study treatment regimen. II. To estimate the frequency of CD30 loss in patients following resistance to brentuximab vedotin. III. To describe the pattern of CD30 expression (membranous, cytoplasmic, Golgi) in comparison to the pre-brentuximab vedotin expression. IV. To semi-quantitatively estimate and compare the surface density of CD30 pre and post brentuximab vedotin as measured by flow cytometry. V. To correlate response with CD30 density as measured by flow cytometry. VI. To evaluate the tolerability of the weekly regimen in patients previously exposed to brentuximab vedotin. OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months for 1 year, and then every 6 months for 4 years.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Washington.