Clinical Trials at DKTK
The effectiveness and safety of new active substances, biomarkers, treatment and diagnostic approaches are first tested in a preclinical phase on cell cultures and animal models. Within the DKTK, special mouse and cell culture systems are being developed that produce results that can be transferred to the human immune system. The effectiveness, dosage and safety of the new treatment and diagnostic concepts are then checked in clinical trials lasting months or years. Promising approaches are then developed further in the laboratory and optimised before going through further clinical control phases. The research focus within the DKTK is on clinical phases I and II. A short description of some DKTK clinical trials is presented in the following. All trials conducted within DKTK can be found in the trial registry of the Clinical Communication Platform.
In the multicenter “AMPLIFY NEOVAC” clinical study DKTK investigators explore a combination immunotherapy for treatment of aggressive brain tumors, malignant glioma. The approach is to boost tumor vaccination, previously developed within DKTK, with so-called immune checkpoint inhibitors (ICIs), which have shown impressive therapeutic activity for other tumors by unblocking the patient’s own immune system. In this trial the immunotherapy will be initiated before a planned resection. The aim of the study is to assess efficacy and to analyze intratumoral anti-tumor immune effects of the combined vaccination/ICI treatment using detailed molecular and immunological studies. These analyses are expected to reveal important mechanisms of response and resistance to targeted immunotherapy in brain tumors.
The clinical 'IvacALL' study is currently investigating the effectiveness of tumour vaccines in children suffering from leukaemia. Relapses after chemo or stem cell therapy are a major problem. Here, customized vaccines open up new treatment options: Children's immune systems are able to recognize the protein changes in tumour cells and to fight them. Therapeutic vaccines using altered protein fragments, or peptides can direct immune cells specifically to the tumour.
As a first step the DNA of both the patient's tumour and their normal healthy tissue extensively analyzed in order to identify the cancer-specific alterations. Following on from that, each patient is vaccinated with a personalized peptide cocktail. The tumour database, which was developed in the course of the study forms the basis of improved treatment options for children in the long-term. The technical progress in genome sequencing in recent years has made these large datasets available for individual therapies.
In this trial, physicians are testing the effectiveness of a vaccine against a mutation of the IDH-1 protein in patients with brain tumours (gliomas).
The trial is investigating how well the patient’s immune system responds to the peptide vaccine.
N2M2 (Phase I and II)
In this register trial, molecular genetic analysis is carried out on tumour cells from patients with a particularly aggressive form of brain tumour (glioblastoma). Based on the molecular changes identified, clinical trials then develop targeted, personalised treatments.
INFORM (Phase I)
In this register trial, scientists hope to open up new treatment options for children with recurrent cancer and children in the advanced stages of cancer who have run out of conventional treatment approaches. The basis is the analysis of the entire tumour genome at the moment the cancer returns. From this, the researchers can discover which factors stimulate cancer growth and may be able to help the child with one of the new targeted drugs.
RAPS (Phase I and II)
This large-scale trial is designed to help improve colon cancer prevention for people in at-risk families in Germany. The trial participants are divided into risk groups so that experts can offer them individual advice and develop new prevention strategies.
HNprädBio (Phase I and II)
The aim of this trial is to test certain biomarkers that can be used to predict how well radiochemotherapy is likely to work in patients with head and neck tumours.
PSMA (Phase I and II)
This patient trial is investigating how reliably metastases can be identified in patients with prostate cancer using the non-invasive 68Ga-PSMA-11 diagnosis method.
MEMORI (Phase II)
Patients with a tumour of the oesophagus (adenocarcinoma) are often treated with chemotherapy or radiotherapy before an operation to reduce the size of the tumour. However this pre-op treatment is not successful in all patients. The trial is studying new biomarkers which can be used to divide patients into prognosis groups.
PORTAF (Phase II)
Radiotherapy is often used after an operation to reduce the risk of a recurrence. This trial is comparing the effectiveness of different radiotherapy methods for lung cancer.
Oli-P (Phase II)
This trial is investigating the effectiveness of high-dose radiotherapy in patients with metastasizing prostate cancer.
ReKo (Phase II)
Head and neck tumours are currently treated primarily with radiotherapy, chemotherapy and operative methods. This trial is studying the effectiveness and safety of high-dose proton therapy in patients with recurrent head and neck tumours.
This trial is comparing the effectiveness and safety of various chemotherapy combinations in patients with lung cancer. Scientists are also using the trial material to research the molecular mechanisms that lead to therapy resistance in some lung cancer cases.
Patients with recurrent acute myeloid leukaemia (AML) are being studied to see to what extent further development of the tumour can be delayed or prevented by the active cytostatic substance 5-azacytidine. The scientists also plan to use blood samples to identify new genetic markers that can be used to estimate the probability of recurrence in advance.
Karsten Spiekermann (Partner Site München)
Christian Thiede (Partner Site Dresden)
Radioactively marked amino acid 11C-methionine is often used to detect tumour cells during positron emission tomography (PET). This trial is checking how reliably the method can be used to predict the time and location of a potential recurrence in the case of malignant brain tumours.
In this trial the efficacy of the drug ATRA is tested in combination with the LSD-1 inhibitor Tranylcypromin in patients with acute myeloid leukemia.