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Dose Escalation Study to Evaluate Safety and Tolerability of an Allogeneic Tumor Vaccine BIWB 2 in Patients With Advanced Malignant Melanoma

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. Identifier: NCT02203864
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Evaluation of safety and tolerability of four intradermal injections given at two week intervals. In addition the efficacy of transferrinfection was determined by quantifying Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic melanoma cells at the injection sites. Further determination of tumor specific and clinical host responses induced or augmented by the treatment were determined.

Condition or disease Intervention/treatment Phase
Melanoma Biological: BIBW2 component A Biological: BIBW2 component B Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Controlled, Combined Parallel Group and Dose Escalation (0, 0.12, 1.2, 12.0 µg IL-2/10**8 Cells/24 Hours) Study, to Evaluate the Safety and Tolerability of an Allogeneic Tumor Vaccine BIWB 2 Containing Melanoma Cells Transfected With the Human IL-2 Gene in Patients With Advanced Malignant Melanoma
Study Start Date : August 1998
Actual Primary Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: BIBW2 with IL-2 secreting cell line Biological: BIBW2 component B
BIBW2 with IL-2 secreting cell line

Experimental: BIBW2 without IL-2 secreting cell line Biological: BIBW2 component A
BIBW2 without IL-2 secreting cell line

Primary Outcome Measures :
  1. Occurrence of dose limiting toxicity (DLT) [ Time Frame: up to 6 weeks ]
  2. Number of patients with adverse events [ Time Frame: up to 28 days after the last vaccination ]

Secondary Outcome Measures :
  1. Grading of local reactions on a 4-point-scale [ Time Frame: up to 28 days after the last vaccination ]
  2. Number of patients with IL-2 transcripts in biopsies of injection sites [ Time Frame: 4-6 and 48 hours after first vaccination ]
  3. Number of patients with delayed type hypersensitivity skin reaction [ Time Frame: up to 28 days after the last vaccination ]
    delayed type hypersensitivity testing

  4. Number of antigen-positive cells in biopsies from metastatic lesions [ Time Frame: up to 28 days after the last vaccination ]
  5. Number of antigen-positive cells in the cellular infiltrate at the vaccination site [ Time Frame: up to 28 days after the last vaccination ]
  6. Number of patients with a positive reaction to Multitest Merieux [ Time Frame: up to day 14 ]
    positive reaction: sum of all indurations of all existing reactions => 10 mm (male) or >= 5 mm (female)

  7. Change in T cell proliferation as ratio of post-vaccination to pre-vaccination [ Time Frame: up to 28 days after the last vaccination ]
  8. Change in S-100 beta protein level in serum [ Time Frame: up to 28 days after the last vaccination ]
  9. Number of patients with clinical response [ Time Frame: up to 28 days after the last vaccination ]
    clinical response = complete and partial response

  10. Change in interferon-gamma secretion as ratio of post-vaccination to pre-vaccination [ Time Frame: up to 28 days after the last vaccination ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients who fail to respond to conventional therapy or for whom conventional therapy is not available
  • Metastatic melanoma (stage IV AJCC) which is surgically or medically incurable because of distant metastatic disease (i.e., a metastasis not in the same lymph node draining area as the primary malignant melanoma). Histologic confirmation of stage IV is required. Measurable disease that can be routinely assessed by physical examination and/or non-invasive radiological procedures
  • Karnofsky performance status is at least 60% and life expectancy greater than 4 months
  • Male or female, minimum age 18 years
  • Written informed consent of the patient in accordance with good clinical practice and local legislation
  • Availability of material for autologous Delayed Type Hypersensitivity (DTH) testing (material derived from autologous melanoma metastases and in-house preparation successful) is a requisite for entering the study
  • Patients have to undergo biopsy of at least one metastasis before the first and after the last vaccination

Exclusion Criteria:

  • Patient who have received any chemotherapy, corticosteroids, radiotherapy (stereotactic irradiation permitted), immunotherapy (e.g. Granulocyte Macrophage Colony Stimulating Factor, Granulocyte Colony Stimulating Factor) or any other investigational drugs in the 4 weeks prior to the first vaccination or prior to surgical removal of tumor specimens for DTH material preparation (patients are not permitted to receive such therapies 4 weeks prior to first cell inoculation except of tumor reductive surgery which are medically indicated)
  • Patients with active intracranial metastases (CT/MRI) or choroidal melanoma
  • Patients with active autoimmune disease
  • Patients with organ allografts
  • Patients with evidence of one or more of the following infections: HIV-1, HIV-2, Hepatitis B Virus, Hepatitis C Virus, Human T lymphotropic Virus-1
  • Patients with active systemic infections or other major medical illness of the cardiovascular organ system [e.g. coronary heart disease (New York Heart Association class III or IV), history of clinically significant ventricular arrhythmias or angina], coagulation disorder, respiratory or nervous system disorder or with severe endocrinological disease
  • Women of childbearing potential with a positive pregnancy test or without appropriate contraception (e.g. IUD [ Intra-Uterine Device], oral contraceptives) until at least 28 days after the last vaccination
  • Lactating women
  • Impaired renal or hepatic function (serum creatinine > 1.5 mg/dl or creatinine clearance < 75 ml/min). In amendments 1 and 3 serum creatinine levels were changed to 2.5 mg/dl and creatinine clearance was reduced to 30 ml/min
  • Impaired hematologic function with:

    • White Blood Count (WBC) < 2500/mm**3 or
    • absolute lymphocyte count < 1500/mm**3 or
    • hemoglobin < 8 g/dl or
    • platelets < 100,000/mm**3
  • Evidence for the existence or history of other malignant neoplasms (except adequately treated basal cell carcinoma and carcinoma in situ of the cervix)
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02203864    
Other Study ID Numbers: 1155.2
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas