Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma
Recruitment status was Recruiting
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.
Unresectable Stage III or Stage IV Melanoma
Biological: Ofatumumab plus Dacarbazine
|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|
- 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
- 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 ]
|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)|
|Experimental: Ofatumumab alone||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376713
|Contact: Stephan N Wagner, MD||+43 1 40 400 ext email@example.com|
|Contact: Procher Verena, MD||+43 1 40 400 ext firstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Stephan N Wagner, MD + 43 1 40400 ext 7705 email@example.com|
|Rudolfstiftung||Not yet recruiting|
|Vienna, Austria, 1030|
|Contact: Klemens Rappersberger, Prof. Dr. +43 1 711 65 ext 2701 firstname.lastname@example.org|
|Principal Investigator:||Stephan N Wagner, MD||Medical University of Vienna|
|Principal Investigator:||Klemens Rappersberger, Prof. Dr.||Hospital Rudolfstiftung|