Trial record 1 of 2 for:    multiferon
Previous Study | Return to List | Next Study

NAM-Trial: Multiferon in Malignant Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Benjamin Weide, M.D., University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01341158
First received: April 19, 2011
Last updated: December 8, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University Hospital Tuebingen:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ 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 ]

Estimated Enrollment: 42
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Claus Garbe, Prof. Dr. +49 (0) 7071/ 298 7110 claus.garbe@med.uni-tuebingen.de
Contact: Benjamin Weide, M.D. +49 7071 2984555

Locations
Germany
Universitätshautklinik Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Claus Garbe, Prof. Dr.         
Principal Investigator: Claus Garbe, Prof. Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: Benjamin Weide, M.D., Dr. Benjamin Weide, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01341158     History of Changes
Other Study ID Numbers: 5021000
Study First Received: April 19, 2011
Last Updated: December 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 01, 2014