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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Melanoma

Treatments

Biological: BIBW2 component A

Biological: BIBW2 component B

Study type

Interventional

Funder types

Industry

Identifiers

NCT02203864

1155.2

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)