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Trial record 1 of 2 for:    multiferon
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NAM-Trial: Multiferon in Malignant Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01341158
First Posted: April 25, 2011
Last Update Posted: November 13, 2014
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.
Information provided by (Responsible Party):
Benjamin Weide, M.D., University Hospital Tuebingen
  Purpose
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.

Condition Intervention Phase
Locoregional Metastases in Malignant Melanoma Stages IIIB/C Drug: human interferon-α Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial

Resource links provided by NLM:


Further study details as provided by Benjamin Weide, M.D., University Hospital Tuebingen:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: after 4 weeks of treatment ]
    Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC)


Secondary Outcome Measures:
  • Disease control rate [ Time Frame: after 4 weeks of treatment ]
    Disease control rate (CR + PR +SD) according to irRC

  • Rate of histopathological complete responses [ Time Frame: after 4 weeks of treatment ]
    Rate of histopathological complete responses

  • Tolerability [ Time Frame: after 4 weeks of treatment ]
    Assessment of numbers of adverse events

  • Differences in gene expression in metastatic tissue before/after treatment [ Time Frame: after 4 weeks of treatment ]
  • Dose dependency of effects [ Time Frame: after 4 weeks of treatment ]
  • Changes of serum markers and PBMC subsets before/after treatment (optional translational side studies) [ Time Frame: after 4 weeks of treatment ]

Enrollment: 42
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven cutaneous melanoma
  2. Clinical stage IIIB or IIIC (AJCC 2010)
  3. ≥ 18 years of age
  4. Presence of at least two metastases, not more than 10 metastases, and completely resectable
  5. 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)
  6. ECOG performance status of 0/1
  7. 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.
  8. 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.

  9. Signed and dated informed consent informed consent before the start of specific protocol procedures

Exclusion Criteria:

  1. Mucous membrane or ocular melanoma
  2. Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
  3. 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).
  4. ALAT or ASAT > 2 x ULN
  5. Total bilirubin > 2 x ULN
  6. Creatinine > 2 x ULN
  7. 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.
  8. Patients with seizure disorders requiring anticonvulsant therapy
  9. Any of the following abnormal baseline hematologic/laboratory values:

    Hb < 10g/dl WBC < 3.0x109 /l Platelets < 100x109 /l

  10. Presence of active autoimmune disease
  11. Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
  12. Unwilling or unable to comply with the requirements of the protocol
  13. Known infection with HBV, HCV, HIV
  14. Pregnant or lactating women
  15. 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
  16. Known or suspected allergy to human interferon alpha or any ingredient of the IMP.
  17. Any thyroid dysfunctions not responsive to therapy
  18. Presence of chronic hepatitis with decompensated liver cirrhosis
  19. Immunosuppression in patients with transplantation
  20. Evidence or history of bleeding diathesis or coagulopathy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01341158


Locations
Germany
Universitätshautklinik Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

Responsible Party: Benjamin Weide, M.D., Dr. Benjamin Weide, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01341158     History of Changes
Other Study ID Numbers: 5021000
First Submitted: April 19, 2011
First Posted: April 25, 2011
Last Update Posted: November 13, 2014
Last Verified: November 2014

Keywords provided by Benjamin Weide, M.D., University Hospital Tuebingen:
Malignatn Melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents