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Brentuximab Vedotin in Treating Patients With Relapsed or Refractory CD30+ Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01703949
First received: October 8, 2012
Last updated: December 2, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
CD30-Positive Neoplastic Cells Present
Recurrent Hodgkin Lymphoma
Recurrent Non-Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Drug: Brentuximab Vedotin
Other: Laboratory Biomarker Analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Weekly Brentuximab Vedotin in Patients With CD30+ Malignancies Refractory to Every ≥ 3 Week Brentuximab Vedotin

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Overall response rate as measured by the Cheson 2007 criteria [ Time Frame: Up to 5 weeks after completion of study treatment ]
    No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is >= 20%.


Enrollment: 8
Study Start Date: March 2013
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (brentuximab vedotin)
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.
Drug: Brentuximab Vedotin
Given IV
Other Names:
  • ADC SGN-35
  • Adcetris
  • Anti-CD30 Antibody-Drug Conjugate SGN-35
  • Anti-CD30 Monoclonal Antibody-MMAE SGN-35
  • Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35
  • cAC10-vcMMAE
  • SGN-35
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703949

Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ajay Gopal Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01703949     History of Changes
Other Study ID Numbers: 7808
NCI-2012-01696 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7808 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: October 8, 2012
Last Updated: December 2, 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017