Trial record 1 of 2 for:
NAM-Trial: Multiferon in Malignant Melanoma
This study has been completed.
Information provided by (Responsible Party):
Benjamin Weide, M.D., University Hospital Tuebingen
First received: April 19, 2011
Last updated: November 11, 2014
Last verified: November 2014
The current clinical trial shall clarify the efficacy, safety and biologic effects of neoadjuvant treatment with natural interferon-α (Multiferon) in patients with locoregional metastases of melanoma in stage IIIB/C.
Locoregional Metastases in Malignant Melanoma Stages IIIB/C
Drug: human interferon-α
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial
Primary Outcome Measures:
Secondary Outcome Measures:
- Disease control rate [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
Disease control rate (CR + PR +SD) according to irRC
- Rate of histopathological complete responses [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
Rate of histopathological complete responses
- Tolerability [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: Yes ]
Assessment of numbers of adverse events
- Differences in gene expression in metastatic tissue before/after treatment [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
- Dose dependency of effects [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: Yes ]
- Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies) [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Experimental: Experimental arm
Drug: human interferon-α
Neoadjuvant treatment: Multiferon is given as flat dosages (3 - 9 - 18 MIU) 5 days per week, subcutaneously for 4 weeks
Other Name: Multiferon
The study is an open label, multicenter phase IIa clinical trial which is designed as a pilot project in order to establish the efficacy and tolerability of Multiferon as a neoadjuvant treatment of locoregional metastases. Patients will be treated subsequently in cohorts characterized by different doses (3 - 9 - 18 MIU) to analyze dosage dependent effects.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically proven cutaneous melanoma
- Clinical stage IIIB or IIIC (AJCC 2010)
- ≥ 18 years of age
- Presence of at least two metastases, not more than 10 metastases, and completely resectable
- Measurable disease (at least one lesion that can be accurately measured in two perpendicular diameters, with both dimensions at least 10 mm x 10 mm for spiral CT and 5 mm x 5 mm for locoregional metastases assessed by ultrasound or digital photography)
- ECOG performance status of 0/1
- Patients with previous adjuvant recombinant interferon-α treatment of any dose are eligible if (i) treatment was stopped at least 1 month before start of treatment and (ii) no progression occurred during interferon-α treatment.
No childbearing potential or negative pregnancy test within 14 days before inclusion in women with child bearing potential Women with childbearing potential must be using an effective method of contraception (Pearl-Index < 1, e.g. oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, spermicides]) throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
No men of fathering potential or men of fathering potential must be using an effective method of contraception to avoid conception throughout the study and for up to 3 months after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized.
- Signed and dated informed consent informed consent before the start of specific protocol procedures
- Mucous membrane or ocular melanoma
- Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
- ALAT or ASAT > 2 x ULN
- Total bilirubin > 2 x ULN
- Creatinine > 2 x ULN
- Evidence or history of depression. If this condition can not be ruled out, the patient should be transferred to a psychiatrist for consultation and further assessment before inclusion.
- Patients with seizure disorders requiring anticonvulsant therapy
Any of the following abnormal baseline hematologic/laboratory values:
Hb < 10g/dl WBC < 3.0x109 /l Platelets < 100x109 /l
- Presence of active autoimmune disease
- Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
- Unwilling or unable to comply with the requirements of the protocol
- Known infection with HBV, HCV, HIV
- Pregnant or lactating women
- Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
- Known or suspected allergy to human interferon alpha or any ingredient of the IMP.
- Any thyroid dysfunctions not responsive to therapy
- Presence of chronic hepatitis with decompensated liver cirrhosis
- Immunosuppression in patients with transplantation
- Evidence or history of bleeding diathesis or coagulopathy
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: NCT01341158
|Tübingen, Germany, 72076 |
University Hospital Tuebingen
No publications provided
||Benjamin Weide, M.D., Dr. Benjamin Weide, University Hospital Tuebingen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 19, 2011
||November 11, 2014
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by University Hospital Tuebingen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas