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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

NCT02203864 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-07-31

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

BIBW2 component A

BIBW2 without IL-2 secreting cell line

BIOLOGICAL

BIBW2 component B

BIBW2 with IL-2 secreting cell line

Sponsors & Collaborators

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Primary Completion
2001-02-28

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203864 on ClinicalTrials.gov