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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Locoregional Metastases in Malignant Melanoma Stages IIIB/C

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

Overall response rate (clinical and radiological) after 4 weeks of treatment (CR + PR) according to immune-related response criteria (irRC)

Outcome Time Frame:

after 4 weeks of treatment

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

5021000

NCT ID:

NCT01341158

Start Date:

April 2011

Completion Date:

June 2012

Related Keywords:

  • Locoregional Metastases in Malignant Melanoma Stages IIIB/C
  • Malignatn Melanoma
  • Melanoma
  • Neoplasm Metastasis

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