- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376713
Anti-CD20 (Cluster of Differentiation Antigen 20) Therapy to Treat Metastatic Melanoma
CD20-Immunotargeting in Metastatic Melanoma Patients- A Prospective, Open Label, Sequential Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna
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Vienna, Austria, 1030
- Rudolfstiftung
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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).
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Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks
Other Names:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Disease control according to RECIST v. 1.1 criteria
Time Frame: 24 weeks
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Disease control according to RECIST v. 1.1 criteria until week 24
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: approximately 2 years
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approximately 2 years
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Assessment of progression-free survival (PFS)
Time Frame: approximately 2 years
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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.
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approximately 2 years
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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
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in patients' blood and tumor samples
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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
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Duration of disease control
Time Frame: approximately 2 years
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approximately 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan N Wagner, MD, Medical University of Vienna
- Principal Investigator: Klemens Rappersberger, Prof. Dr., Hospital Rudolfstiftung
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Ofatumumab
- Antibodies, Monoclonal
- Dacarbazine
Other Study ID Numbers
- EudraCT: 2010-023277-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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