Trial record 3 of 273 for:    Open Studies | "Hodgkin Disease"

Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Northwestern University
Sponsor:
Collaborators:
Robert H. Lurie Cancer Center
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01476410
First received: October 18, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.


Condition Intervention Phase
Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Adult Mixed Cellularity Hodgkin Lymphoma
Adult Nodular Sclerosis Hodgkin Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage IV Adult Hodgkin Lymphoma
Drug: brentuximab vedotin
Drug: doxorubicin hydrochloride
Drug: vinblastine
Drug: dacarbazine
Procedure: quality-of-life assessment
Genetic: DNA analysis
Genetic: RNA analysis
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: polymorphism analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Overall response rate after chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary objective of this study is to assess the overall response rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study ] [ Designated as safety issue: No ]
    Overall response rate progression-free survival (PFS), time to treatment failure (TTF), freedom from progression (FFP), and overall survival (OS) rates following SGN-35/AVD sequential therapy.

  • Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]) [ Time Frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study ] [ Designated as safety issue: No ]
    Estimates of response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD])


Estimated Enrollment: 48
Study Start Date: November 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (antibody-drug conjugate and combination chemo)

LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: brentuximab vedotin
Given IV
Other Names:
  • anti-CD30 ADC SGN-35
  • anti-CD30 antibody-drug conjugate SGN-35
  • antibody-drug conjugate SGN-35
  • SGN-35
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: vinblastine
Given IV
Other Names:
  • Velban
  • Velsar
  • VLB
Drug: dacarbazine
Given IV
Other Names:
  • DIC
  • DTIC
  • DTIC-Dome
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Genetic: DNA analysis
Optional correlative studies
Genetic: RNA analysis
Optional correlative studies
Radiation: fludeoxyglucose F 18
Correlative studies
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Correlative studies
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: laboratory biomarker analysis
Optional correlative studies
Other: immunohistochemistry staining method
Optional correlative studies
Other Name: immunohistochemistry
Genetic: polymorphism analysis
Optional correlative studies

Detailed Description:

LEAD IN: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible
  • Stage II, III, and IV disease by Ann Arbor classification
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration
  • Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration
  • Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 45%
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelet count > 75,000/mm^3
  • Creatinine < 2.5 mg/dl
  • Bilirubin < 3.0 mg/dl
  • Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters
  • Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma
  • Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
  • Patients must sign the informed consent form before registration

Exclusion Criteria:

  • Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy
  • History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])
  • Known cerebral/meningeal disease
  • Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
  • Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally [po] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended
  • Patients with a known hypersensitivity to any excipient contained in the drug formulation
  • Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
  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: NCT01476410

Contacts
Contact: Study Coordinator (312)695-1301 cancertrials@northwestern.edu

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Ranjana H. Advani, MD    650-725-6456      
Principal Investigator: Ranjana H. Advani, MD         
United States, Illinois
NorthwesternU Recruiting
Chicago, Illinois, United States, 60611
Contact: Leo I. Gordon    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Leo I. Gordon, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Sonali M. Smith, MD         
Principal Investigator: Sonali M. Smith, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andrew M. Evens, DO, MSc    617-636-6227      
Principal Investigator: Andrew M. Evens, DO, MSc         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-7835
Contact: Gregory Bociek, MD    402-559-5388      
Principal Investigator: Gregory Bociek, MD         
United States, New York
Memorial Sloan- Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Paul A. Hamlin, MD    212-639-6143      
Principal Investigator: Paul A. Hamlin, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Michelle Fanale, MD    713-792-2860      
Principal Investigator: Michelle Fanale, MD         
Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Seattle Genetics, Inc.
Investigators
Principal Investigator: Leo Gordon Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01476410     History of Changes
Other Study ID Numbers: NU 11H01, NCI-2011-00684, STU00046908
Study First Received: October 18, 2011
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Sclerosis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Immunoconjugates
Dacarbazine
Doxorubicin
Vinblastine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 26, 2014