Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003619

Trial Description

start of 1:1-Block title

Title

Neoadjuvant Treatment of Locoregional Metastases in Malignant Melanoma (AJCC Stage IIIB/C) With Multiferon: a Phase IIa DeCOG Trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003619
  •   2012/04/18
  •   2011/04/19
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01341158  (ClinicalTrials.gov)
  •   5021000  (University Hospital Tuebingen)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Locoregional Metastases in Malignant Melanoma Stages IIIB/C
  •   C43 -  Malignant melanoma of skin
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: human interferon-α
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2011/04/30
  •   42
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University Hospital Tuebingen
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Claus Garbe, Prof. Dr. 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Claus Garbe, Prof. Dr. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.