Using genome and RNA analysis to guide treatment for advanced rare cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program uses comprehensive tumor profiling — whole-genome/exome sequencing, RNA sequencing and genome-wide DNA methylation — to generate molecularly informed treatment recommendations reviewed by a molecular tumor board. Eligible adults with locally advanced or metastatic rare epithelial or mesenchymal cancers provide a fresh biopsy or recent frozen tumor sample and clinical data. The molecular recommendations are used to guide treatment choices and patient outcomes such as response and disease control are tracked and compared to standard care outcomes. The approach builds on the DKFZ/NCT/DKTK MASTER workflow and aims to expand personalized options for patients who have progressed after at least one standard therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18years, no upper age limit
* Patients with locally advanced and/or metastatic rare epithelial or mesenchymal cancer (equal numbers of patients) without curative treatment option
* Progressive disease or expected progression of the disease estimated by clinical parameters, suitable biomarkers, and other (e.g. radiographic) methods \* At least one measurable lesion that has been accurately assessed by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline and is amenable to repeat evaluation in MRI/CT images
* Patients must have received at least one standard therapy for advanced disease according to current guidelines or consensus recommendations or have no standard therapy available
* Possibility to perform fresh tumor biopsy according to local SOPs or Availability of fresh frozen tumor samples with sufficient tumor cell content collected within 3 months prior to enrolment
* ECOG PS ≤ 2.
* Ability of patient to understand character and consequences of the clinical trial
* Patient must be willing and able to undergo subsequent treatment (e.g. in a clinical trial) with molecularly guided therapy according to the MTB recommendation
* Availability of complete information about all medical treatment given before study participation, i.e. remission status before start of treatment, dosage and timing of drugs applied, remission status and date of progression after treatment

Exclusion Criteria:

* Dementia or significant cognitive impairment
* Epilepsy requiring pharmacologic treatment
* Prior allogeneic bone marrow or solid organ transplantation
* Hematological malignancies and primary brain tumors.
* Prior comprehensive molecular profiling by WGS, WES, RNA-Seq, or large targeted panels.
* Patients with symptomatic or uncontrolled brain metastases and patients with symptomatic or uncontrolled spinal cord compression. Patients with previously treated brain metastases are eligible, provided that the patient has neither experienced a seizure nor had a clinically significant change in neurological status within the three months prior to enrollment. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month, both prior to study enrollment.
* Malignancy other than study indication within the last 5 years except: curatively treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, low-risk prostate cancer, or other malignancies curatively treated with no evidence of disease for ≥5 years.
* History of intracranial hemorrhage or spinal cord haemorrhage; no ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted
* Known uncontrolled or significant cardiovascular disease, including any of the following:
* History of heart failure NYHA class 3 or 4
* History of uncontrolled angina pectoris, arrhythmias, or myocardial infarction within 12 months prior to screening.
* History of liver cirrhosis
* Neurologic or psychiatric disorder interfering with ability of giving informed consent.
* Known or suspected active alcohol or drug abuse.
* Patients with inability to receive oral medications.
* Failure to provide consent for the registration, storage, and processing of individual disease characteristics and clinical course, as well as for informing the primary care physician about the participant's involvement in the study.

Where it's running

• Universitätsklinikum Augsburg
  Augsburg, Germany Recruiting
• Charité Berlin
  Berlin, Germany Recruiting
• Universitäts-Klinikum Köln
  Cologne, Germany Recruiting
• Medizinische Fakultät der TU Dresden
  Dresden, Germany Recruiting
• Uniklinikum Erlangen
  Erlangen, Germany Recruiting
• Universitätsmedizin Essen
  Essen, Germany Recruiting

Study contacts

• Principal investigator: Stefan Fröhling, MD — German Cancer Research Center
• Study coordinator: Trial Management and Support, NCT Heidelberg Clinical Trial Center
• Email: rationale_pm@nct-heidelberg.de
• Phone: 49 6221 566553

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.