Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Viscum album peptide

European Mistletoe

The test group will receive the mistletoe extract Iscador® Qu as supportive treatment in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

The parallel control group will receive no mistletoe but only post-operative conventional oncological therapy (radio-, chemo-, targeted therapy).

Gerhard M Stauder, PhD

Thomas Stein, MD

Leo Auerbach, Prof. MD

Dirk Behringer, Prof. MD

Andrea Distelrath, MD

Thomas Seufferlein, Prof. M.D.

Florian Glaser, MD

Volker Heinemann, Prof. MD

Eckhard Böcher, Prof. MD

Götz PL von Wichert, MD

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years.

Prospective observational confirmation study of previous retrospective cohort study.

As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)

Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Colorectal Cancer Stages UICC II-IV

As key symptom, the fatigue syndrome will be evaluated separately.

Adverse events (local and/or systemic) contributable to Iscador® Qu

Hiscia Society for Cancer Research

IFAG Basel AG (CRO), both Switzerland

IFAG AG

Pharmaceutical Solutions

Platelet Aggregation Inhibitors

Other Dietary Supplements

Pycnogenols

Investigational therapy will be administered in six Dose Groups (DG):

10 mg, 20 mg, 40 mg, 90 mg, 140 mg and 200 mg Iscador®P. The initial dose group of the study is set to 40 mg Iscador®P. The two lower dose groups (20 or 10 mg) will only be used in case of intolerance at 40 mg Iscador®P. Once per week patients receive intravenous infusions of Iscador®P dissolved in 250 ml of sodium chloride solution (0.9 %). After the 4-week period of the MTD estimation phase each subject will immediately be included into a follow up observation in which he/she receives the last well tolerated dosage they had or the next lower dosage than the currently investigated DG in the running phase Ib study depending on the current estimate of the MTD at that time.

Iscador®P: fermented aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum (Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany, Austria, Sweden, and South Korea in dosages up to 20 mg.

Intravenous Solution

Gil Bar Sela, Prof

Ela Lutwak, M.SC

Ela Lutwak, MSC

Prospective, dose-escalating mono-center open label dose-finding study without control group (3+3 design), including a follow-up on-treatment observation. In this study will be recruited 15 patients with a histologically or cytologically confirmed diagnosis of an advanced malignant disease during a therapy-free interval.Investigational drug:Iscador®P: fermented aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum (Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany, Austria, Sweden, and South Korea in dosages up to 20 mg.

The initial dose group of the study is set to 40 mg Iscador®P.

This is a prospective open label dose finding study (phase I) of Iscador®P in patients with histological or cytological confirmed diagnosis of an advanced malignant disease during a therapy-free interval. Primary objective : To determine the maximum tolerated dose (MTD) of Iscador®P as intravenous infusion in the aforementioned patient population, based on the incidence of dose-limiting toxicities (DLTs). Secondary objective :To investigate safety and tolerability of long-term intravenous infusion of Iscador®P based on incidence and severity of adverse drug reactions.

All patients are receiving best supportive care and may receive, if necessary, specified concomitant therapies, which should not interfere with the safety parameters chosen for this study.

Investigational therapy will be administered in six Dose Groups (DG): 10 mg, 20 mg, 40 mg, 90 mg, 140 mg and 200 mg Iscador®P. The initial dose group of the study is set to 40 mg Iscador®P.

The two lower dose groups (20 or 10 mg) will only be used in case of intolerance at 40 mg Iscador®P. Once per week patients receive intravenous infusions of Iscador®P dissolved in 250 ml of sodium chloride solution (0.9 %). After the 4-week period of the MTD estimation phase each subject will immediately be included into a follow up observation in which he/she receives the last well tolerated dosage they had or the next lower dosage than the currently investigated DG in the running phase Ib study depending on the current estimate of the MTD at that time.

Study entry of individual patients will be set apart by one week. Dosages of subsequent dose groups depend on the incidence of DLTs in former groups.

For safety reasons the values of endotoxin content in Iscador®P, measured by the limulus test, are considered as the real content of endotoxins although the mistletoe lectins are cross reacting in this test. This leads to a maximum dose of 200 mg representing the upper limit of this dose finding study.

Prospective, dose-escalating mono-center open label dose-finding study without control group (3+3 design), including a follow-up on-treatment observation.

A Prospective Dose Finding Study of Iscador Infusion

A Prospective Dose Finding Study of Iscador Infusion: Phase Ib Study With Prolonged Observation (ISINFULA)

Maximum tolerated dose (MTD) of Iscador®P infusions, i.e. the dose eliciting dose-limiting toxicities (DLTs) in a maximum of 1 out of 6 patients treated at that dose.treated at that dose.

The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants.

frequency of ADRs to intravenous mistletoe treatment will be measured during the study.

Evaluation of tumor response will be according to the RECIST criteria V1.1

Time to disease progression will be defined as the time from first infusion of Iscador®P to the date of documentation of disease progression.

Overall survival will be measured from the date of first infusion of Iscador®P until the date of the last follow-up or death.

HaEmek Medical Center, Israel

Symptoms and General Pathology

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Osteosarcoma

Sarcoma

Neoplasm Metastasis

Bone Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Immunomodulating Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Each Iscador® P therapy begins with a dose finding phase related to the drug' immunogenicity. In this phase, gradually increasing doses are used to determine the optimum individual dose response of the patient and to prevent excessive toxicity. The Iscador® P will be administered three times per week by subcutaneous injections (M,W,F) into the subcutaneous tissue of the thigh or abdomen. Treatment is administered according to a series of escalating doses that are given each of the three days in a week for 7 doses. There are 3 different series (Series 0, 1, and 2) and there are 7 dose vials in each series. Once the patient has reached their maximum tolerated dosing series, that series is used as the treatment regimen for the remaining weeks to a total duration of 52 weeks (13 cycles) or until disease progression. Each cycle is 4 weeks.

Iscador P given for 2 cycles with follow up imaging done every 2 cycles. If imaging is negative patient remains on study for 13 cycles. If new lesion is found, then patient is off study.

Iscador*P

Sherri Mayans, RN

Katharine Offer, MD

Karen Moody, MD

This will be a phase II, single arm study of osteosarcoma patients with fully resected pulmonary metastases. The MTD corresponds to the dosage recommendations of the manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany and Switzerland for the treatment of solid tumors and precancerous lesions.

The study population includes patients with relapse of osteosarcoma in the lung following surgical resection of all gross disease (2nd or greater CR). Following completion of final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD with surveillance imaging via CT scan to monitor for relapsed disease.

This will be a phase II, single arm study of osteosarcoma patients with fully resected pulmonary metastases. The MTD corresponds to the dosage recommendations of the manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany and Switzerland for the treatment of solid tumors and precancerous lesions.

Iscador® P is to be injected subcutaneously (abdominal) 3 times/week. All patients will start with Series 0 (0.01mg, 0.01mg, 0.1mg, 0.1mg, 1mg, 1mg, 1mg). If tolerated, they will receive this series for 2 consecutive boxes (2 x 7 vials per box). This will then be followed by Series 1 (0.1mg, 0.1mg, 1mg, 1mg, 10mg, 10mg, 10mg), which will be administered for the following 2 consecutive boxes (2 x 7 vials per box). If tolerated, patients will proceed to Series 2 (1mg, 1mg, 10mg, 10mg, 20mg, 20mg 20mg), which will be continued through week 52 (13 cycles).

The study population includes patients with relapse of osteosarcoma in the lung following surgical resection of all gross disease (2nd or greater CR). Following completion of final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD with surveillance imaging via CT scan to monitor for relapsed disease.

Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma

MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Osteosarcoma After Resection Of Pulmonary Metastases

To estimate the event free survival for pediatric, adolescent and young adult patients with relapsed pulmonary osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all metastases.

Quality of life assessed with the NIH PROMIS® measures based on the patien's age. The PROMIS® Pediatric Profile v2.0 - Profile-25 and Parent-Proxy will be used for children from age 8 up to 18 years of age. It includes 25 questions with a graded categorical 5-point response scale.

The PROMIS-29 Plus 2 Profile v2.1 for adults is a patient-reported measure of quality of life for adults. It includes 31 questions with a graded categorical 5-point response scale.

Both PROMIS scales have a mean score of 50 and a standard deviation (SD) of 10 in the general population.

Time to relapse in pediatric, adolescent, and young adult patients with relapsed pulmonary osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all metastases.

M.D. Anderson Cancer Center

Iscador AG, Arlesheim, Switzerland.

Tackle Kids Cancer

Susan Zabransky Hughes Foundation

Hackensack Meridian Health

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition to conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 3 years.

Prospective observational confirmation study of previous retrospective cohort study.

As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)

Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Pancreatic Cancer Stages UICC II-IV

IFAG Basel AG, both Switzerland

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Iscar

mistletoe

Steven Rosenzweig, MD

The purpose of this study it to determine whether supplemental treatment with Iscar improves immune function and quality of life among Stage IV non-small cell lung carcinoma patients receiving conventional chemotherapy. Iscar is an herbal medicine made from the total plant extract of mistletoe. this preparation is already in use in Europe and its use in the US is likely to increase as cancer patients continue to seek alternative therapies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)	NCT01448655	Colorectal Canc...		18 Years - 85 Years	IFAG AG
A Prospective Dose Finding Study of Iscador Infusion	NCT04376931	Advanced Cancer	Intravenous Sol...	18 Years -	HaEmek Medical Center, Israel
Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)	NCT01448655	Colorectal Canc...		18 Years - 85 Years	IFAG AG
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma	NCT05726383	Osteogenic Sarc...	Iscador*P	8 Years - 30 Years	Hackensack Meridian Health
Iscador® P (Mistletoe) Immunotherapy for Recurrent Osteogenic Sarcoma	NCT05726383	Osteogenic Sarc...	Iscador*P	8 Years - 30 Years	Hackensack Meridian Health
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)	NCT01448668	Pancreas Cancer		18 Years - 85 Years	IFAG AG
Iscar for Supplemental Care in Stage IV Lung Cancer	NCT00079794	Lung Cancer	Iscar mistletoe	18 Years -	National Center for Complementary and Integrative Health (NCCIH)

Spots Global Cancer Trial Database for mistletoe

Every month we try and update this database with for mistletoe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mistletoe

Every month we try and update this database with for mistletoe cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mistletoe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.