Mistletoe Therapy in Primary and Recurrent Inoperable Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study a mistletoe preparation (Iscador Qu) is added to standard therapy in inoperable pancreatic cancer in order to evaluate effect on overall survival and health-related quality of life. Half of participants will take subcutaneous injections with mistletoe in addition to standard therapy (palliative chemotherapy or best supportive care); the other half will receive a placebo and standard therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Collaborators: Cancerforskningsfonden i Norrland; Dagmar Ferbs Minnesfond; Ekhagastiftelsen; Immunpathologisches Labor, University Tübingen; Karolinska Institutet; Regional Cancer Centre Stockholm Gotland; Signe & Ane Gyllenbergs Stiftelse; Stiftelsen Konung Gustaf V:s Jubileumsfond för cancerforskning; The Sjöberg Foundation; University of Witten/Herdecke
• Treatments: Viscum album peptide

Criteria

Inclusion Criteria:

Signed written informed consent

• Age ≥ 18 years

• Inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.

• Primary diagnosis: if histology is not clinically achievable diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 (=cancer antigen 19-9) and CT).

• Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-9.

• ECOG ( Eastern Cooperative Oncology Group) performance status 0-2 (see table in section 12.14 )

• Adequate negative pregnancy test and adequate contraception (where appropriate)

Exclusion Criteria:

Life expectancy less than 4 weeks

• Pregnancy or breastfeeding

• Neuroendocrine tumors of the pancreas (NET)

• Current use of interferon, G-CSF (granulocyte colony-stimulating factor) and thymus preparations

• Symptomatic brain edema due to brain metastases

• Known hypersensitivity to mistletoe-containing products

• Current use of mistletoe extract preparations in any form

• Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment

• Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).