Clinical trial · Interventional
Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors
Phase I/IIa AdCD40L Immunogene Therapy for Patients With Advanced Malignant Disease.
NCT01455259CI-TRIAL-00020965completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AdCD40L | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AdCD40L
- description
- Treatments once a week with 2.5x10e11 VP AdCD40L, maximum 4 treatments (total dose 1x10e12 VP). If no effect in less than 2 out of 6 melanoma patients, the following 9 melanoma patients and 6 patients with other solid tumors will receive preconditioning therapy 1-2 days prior to first and last treatment with 300mg/m2 cyclophosphamid. The next 9 melanoma patients will receive one local radiotherapy.
- interventionNames
- Biological: AdCD40L
Primary outcomes (2)
- measure
- All cause adverse events
- timeFrame
- during 10 weeks
- description
- Adverse events will be documented such as inflammation, fever, pain, changes in blood pressure, pulse etc.
- measure
- Immune reactions to adenovirus and spreading of vector
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of malignant solid cancer, ECOG 0-2. * Disease progression on established treatments or patients not eligible to standard options. * Signed informed consent must be obtained. Exclusion Criteria: * Pregnancy. * Life expectancy less than 3 months. * Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. * Patients with severe systemic autoimmune disease. * Patients that do not consent to that tissue and blood samples are stored in a biobank.
References
Publications (1)
- DERIVEDSchiza A, Wenthe J, Mangsbo S, Eriksson E, Nilsson A, Totterman TH, Loskog A, Ullenhag G. Adenovirus-mediated CD40L gene transfer increases Teffector/Tregulatory cell ratio and upregulates death receptors in metastatic melanoma patients. J Transl Med. 2017 Apr 20;15(1):79. doi: 10.1186/s12967-017-1182-z. PMID 28427434