Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Stephan N. Wagner, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01376713
First received: June 16, 2011
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess the overall disease control rate of Ofatumumab wo/w Dacarbazine in subjects with American Joint Committee on Cancer (AJCC 2009) unresectable stage III or stage IV melanoma.


Condition Intervention Phase
Unresectable Stage III or Stage IV Melanoma
Biological: Ofatumumab
Biological: Ofatumumab plus Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Disease control according to RECIST v. 1.1 criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Disease control according to RECIST v. 1.1 criteria until week 24


Secondary Outcome Measures:
  • Assessment of progression-free survival (PFS) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
    Assessment of progression-free survival (PFS) defined as the time from first day of treatment to the first documentation of disease progression or death, whichever occurs first.

  • Evaluation of cell biological responses [ Time Frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks ] [ Designated as safety issue: No ]
    in patients' blood and tumor samples

  • Duration of disease control [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab alone Biological: Ofatumumab
Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks
Other Name: Arzerra
Experimental: Ofatumumab plus Dacarbazine Biological: Ofatumumab plus Dacarbazine

Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks.

Dacarbazine administered q4w at a dose of 1000mg/m2, 4 days before next administration of Ofatumumab for 24 weeks.

Other Names:
  • Arzerra
  • DTIC

Detailed Description:

This is a prospective, multicenter, open-label, sequential, 2-cohort, phase 2 study to assess the overall disease control rate of Ofatumumab according to criteria of RECIST (Response Evaluation Criteria in Solid Tumors) v. 1.1. in subjects with unresectable stage III B (T1- 4a, N2b-c), stage III C or stage IV (American Joint Committee on Cancer 2009) disease.

Cohort 1: 10 eligible patients will be treated with ofatumumab alone. If interim analysis shows that at least 1 confirmed overall response occurs, an additional 19 eligible patients will be treated, for a total of 29 patients.

Cohort 2: If no confirmed overall response by ofatumumab alone-therapy is seen in the first 10 patients, cohort 2 will be opened. Initially, 13 eligible patients will be treated with a combination of Dacarbazine plus ofatumumab. If interim analysis gives at least 2 confirmed overall responses, additional 26 patients will be recruited.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Signed informed consent
  • Metastatic non-ocular melanoma - unresectable stage III B (T1- 4a, N2b-c), stage III C (AJCC 2009) or stage IV (AJCC 2009).
  • measurable disease with more than one metastatic lesion, according to RECIST v. 1.1 criteria,
  • One of these metastases must be resectable prior to anti-CD20 therapy.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
  • As soon as BRAF or other kinase inhibitors are standard of care, we will include only patients who cannot be considered for those therapies. E.g. patients with tumors not carrying the respective mutational profile, patients refusing this kind of therapy for any reason, patients being not eligible to those therapies due to contraindications or disease progression under such kind of therapy.
  • Life expectancy of 3 month or longer
  • Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age.

Exclusion Criteria:

  • Patients with active brain metastasis (exception: brain metastases being stable with and without corticosteroids for 2 months after treatment by surgery or radiation therapy) and immunoglobulin-deficiency will be excluded.

Subjects meeting any of the following criteria must not be enrolled in an ofatumumab study:

  • Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
  • Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
  • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
  • HIV positive
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrollment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
  • Positive serology for hepatitis C (HC) defined as a positive test for HCAb (HC antibodies), in which case reflexively perform a HC RIBA (recombinant immunoblot assay) on the same sample to confirm the result
  • Screening laboratory values:

hemoglobin < 8g/dL platelets <70 x 109/L leukocytes <1.5 x 109/L creatinine >2.0 times ULN (upper limit of normal) total bilirubin >1.5 times ULN liver transaminase ALT >2.5 times ULN alkaline phosphatase >2.5 times ULN

  • Pregnant or lactating women
  • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
  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: NCT01376713

Contacts
Contact: Stephan N Wagner, MD +43 1 40 400 ext 7705 stephan.wagner@meduniwien.ac.at
Contact: Procher Verena, MD +43 1 40 400 ext 7857 verena.procher@meduniwien.ac.at

Locations
Austria
Rudolfstiftung Not yet recruiting
Vienna, Austria, 1030
Contact: Klemens Rappersberger, Prof. Dr.    +43 1 711 65 ext 2701    klemens.rappersberger@wienkav.at   
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Stephan N Wagner, MD    + 43 1 40400 ext 7705    stephan.wagner@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stephan N Wagner, MD Medical University of Vienna
Principal Investigator: Klemens Rappersberger, Prof. Dr. Hospital Rudolfstiftung
  More Information

Publications:
Responsible Party: Stephan N. Wagner, MD, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01376713     History of Changes
Other Study ID Numbers: EudraCT: 2010-023277-19
Study First Received: June 16, 2011
Last Updated: April 24, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014