Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT01376713|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stage III Melanoma Stage IV Melanoma||Biological: Ofatumumab Biological: Ofatumumab plus Dacarbazine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study|
|Study Start Date :||June 2011|
|Primary Completion Date :||January 2015|
|Study Completion Date :||May 2015|
Experimental: Ofatumumab alone
Patients with melanoma unresectable stage III B (T1- 4a, N2b-c), stage III C or stage IV (AJCC 2009) will be included in this study. Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks. Tumor imaging is performed at wk 4 (screening for rapid disease progression), 8, 16 and 24. In case of PD, patients will have the opportunity to receive at least 3 cycles of ofatumumab q4w in combination with DTIC (1000 mg/m2) q4w (see Arm2).
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
Patients will be treated with a combination of DTIC (1000 mg/m2) q4w plus ofatumumab (1000mg) qw for 8 wks, and thereafter q4w.Tumor imaging is performed at wk 8, 16 and 24.
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.
- Disease control according to RECIST v. 1.1 criteria [ Time Frame: 24 weeks ]Disease control according to RECIST v. 1.1 criteria until week 24
- Assessment of progression-free survival (PFS) [ Time Frame: approximately 2 years ]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 ]in patients' blood and tumor samples
- Duration of disease control [ Time Frame: approximately 2 years ]
- Overall survival [ Time Frame: approximately 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376713
|Vienna, Austria, 1030|
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Stephan N Wagner, MD||Medical University of Vienna|
|Principal Investigator:||Klemens Rappersberger, Prof. Dr.||Hospital Rudolfstiftung|