Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||January 2015|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|