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Osteogenic Sarcoma RecurrentPhase 2NCT05726383

Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma

A Phase 2 study testing Iscador*P in people with Osteogenic Sarcoma Recurrent, run by Hackensack Meridian Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 8 to 30 years
Conditions the study is for
Osteogenic Sarcoma Recurrent
What is being tested?
Iscador*P
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
14 May 2024to 11 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologic diagnosis of osteosarcoma.
  • Patients with at least one episode of relapse in the lung (without limitation of number of episodes), following surgical resection of all gross metastatic disease.
  • Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 8 weeks prior to study enrollment. Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Patients with positive microscopic margins will be eligible to enroll.
  • Pathological confirmation of metastases from at least one of the resected sites.
  • Age ≥ 8 years of age and <30 years of age.
  • Patients must be able to receive subcutaneous injections.
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  • Performance level as measured by Karnofsky ≥60% for patients > 16 years of age or Lansky ≥ 60% for patients ≤ 16 years of age.
  • Female patients of childbearing potential must have a negative serum blood pregnancy test during screening and a negative urine pregnancy test within 3 days prior to receiving the first dose of study drug. If the screening serum test is done within 3 days prior to receiving the first dose of study drug, a urine test is not required. If a patient is of childbearing potential the patient must agree to use effective contraception during the study and for 120 days after the last dose of study drug.
  • If male, agrees to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug
  • Life expectancy of > two months
  • Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade <1 (except alopecia, cytopenia, or neuropathy). If a patient underwent major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
  • Patients must meet the following laboratory criteria
  • Adequate hepatic function with serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) and total serum bilirubin < 2.5 times the ULN or Direct bilirubin ≤ ULN for patients with total bilirubin levels > 2.5 X ULN
  • Absolute neutrophil count ≥ 500/dL
  • Platelet count ≥ 20,000/L
  • Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance (CrCl) ≥ 60 ml/minute

Who cannot join

  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:
  • Another known malignancy other than osteosarcoma that is progressing or requires active treatment.
  • Any prior history of other cancer within the prior 5 years with the exception of adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ).
  • Active infection requiring systemic therapy.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • New recurrence of osteosarcoma metastasis in any location other than lung
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  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
  • Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [qualitative]). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBc Ab] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Known history of chronic granulomatous diseases, florid autoimmune diseases, diseases treated with immunosuppressive drugs, hyperthyroidism with tachycardia, tuberculosis, parasitosis or Crohn's disease.
  • If female, is pregnant or breastfeeding.
  • Patients must have had no systemic chemotherapy or immunotherapy in the three weeks prior to enrollment and must have fully recovered from side effects of prior treatment at enrollment.
  • Patients may not receive any additional chemotherapeutic agent (either conventional or experimental) while on study.
  • Patients must not have received radiation therapy for up to two weeks prior to enrollment.
  • Patients must have no known prior allergy to Iscador® P or any other Viscum album products.
  • Patients must not receive concomitant treatment with immunostimulant or immunosuppressive drugs.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Goode, MS, RN, PCNS-BC contact

5519964995

laura.goode@hmhn.org

United States2 sites, 2 recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Laura Goode, MS, RN, PCNS-BC, 5519964995, laura.goode@hmhn.org

    Katharine Offer, MD

    Recruiting

  • M.D. Anderson Children's Cancer Hospital

    Houston, Texas, 77030

    Karen Moody, MD, 713-792-2260, kmoody@mdanderson.org

    Karen Moody, MD

    Recruiting

Other trials in United States

About this study

Official title: MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma

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.

Read the detailed description

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.

Being tested
Iscador*P
Keywords
Osteogenic, Sarcoma, Pulmonary, Metastatic, Immunotherapy, Mistletoe, Bone Tumor
Medical subject headings
Sarcoma, Neoplasm Metastasis, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iscador*PDrug

    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.

Study groups in NCT05726383
Study groupRoleWhat they receive
Treatment Arm - Iscador*PExperimentalEach 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.
Receives: Drug: Iscador*P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

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

    Measured: 12-months post complete resection

Secondary outcomes (2)

  1. Quality of life post resection

    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.

    Measured: 12-months post complete resection

  2. Time to relapse

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

    Measured: 12-months post complete resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start14 May 2024
  3. Primary completion11 May 2027 (estimated)
  4. Study completion11 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726383
Sponsor's protocol ID
Pro2021-1524
Status last verified
May 2026
First submitted
3 Feb 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boye K, Longhi A, Guren T, Lorenz S, Naess S, Pierini M, Taksdal I, Lobmaier I, Cesari M, Paioli A, Londalen AM, Setola E, Hompland I, Meza-Zepeda LA, Sundby Hall K, Palmerini E. Pembrolizumab in advanced osteosarcoma: results of a single-arm, open-label, phase 2 trial. Cancer Immunol Immunother. 2021 Sep;70(9):2617-2624. doi: 10.1007/s00262-021-02876-w. Epub 2021 Feb 12.

    PubMed 33580363

  • Bussing A, Regnery A, Schweizer K. Effects of Viscum album L. on cyclophosphamide-treated peripheral blood mononuclear cells in vitro: sister chromatid exchanges and activation/proliferation marker expression. Cancer Lett. 1995 Aug 1;94(2):199-205. doi: 10.1016/0304-3835(95)03850-v.

    PubMed 7634248

  • Bussing A, Stumpf C, Troger W, Schietzel M. Course of mitogen-stimulated T lymphocytes in cancer patients treated with Viscum album extracts. Anticancer Res. 2007 Jul-Aug;27(4C):2903-10.

    PubMed 17695469

  • Chou AJ, Merola PR, Wexler LH, Gorlick RG, Vyas YM, Healey JH, LaQuaglia MP, Huvos AG, Meyers PA. Treatment of osteosarcoma at first recurrence after contemporary therapy: the Memorial Sloan-Kettering Cancer Center experience. Cancer. 2005 Nov 15;104(10):2214-21. doi: 10.1002/cncr.21417.

    PubMed 16206297

  • Gabius HJ, Gabius S, Joshi SS, Koch B, Schroeder M, Manzke WM, Westerhausen M. From ill-defined extracts to the immunomodulatory lectin: will there be a reason for oncological application of mistletoe? Planta Med. 1994 Feb;60(1):2-7. doi: 10.1055/s-2006-959396.

    PubMed 8134410

  • Gabriel AP, Mercado CP. Data retention after a patient withdraws consent in clinical trials. Open Access J Clin Trials. 2011 Apr;3:15-19. doi: 10.2147/OAJCT.S13960.

    PubMed 23935390

  • Horneber MA, Bueschel G, Huber R, Linde K, Rostock M. Mistletoe therapy in oncology. Cochrane Database Syst Rev. 2008 Apr 16;2008(2):CD003297. doi: 10.1002/14651858.CD003297.pub2.

    PubMed 18425885

  • Heinzerling L, von Baehr V, Liebenthal C, von Baehr R, Volk HD. Immunologic effector mechanisms of a standardized mistletoe extract on the function of human monocytes and lymphocytes in vitro, ex vivo, and in vivo. J Clin Immunol. 2006 Jul;26(4):347-59. doi: 10.1007/s10875-006-9023-5. Epub 2006 May 17.

    PubMed 16705487

  • Jung ML, Baudino S, Ribereau-Gayon G, Beck JP. Characterization of cytotoxic proteins from mistletoe (Viscum album L.). Cancer Lett. 1990 May 30;51(2):103-8. doi: 10.1016/0304-3835(90)90044-x.

    PubMed 2344587

  • Klein R, Classen K, Berg PA, Ludtke R, Werner M, Huber R. In vivo-induction of antibodies to mistletoe lectin-1 and viscotoxin by exposure to aqueous mistletoe extracts: a randomised double-blinded placebo controlled phase I study in healthy individuals. Eur J Med Res. 2002 Apr 30;7(4):155-63.

    PubMed 12010650

  • Klein R et al. Effects of mistletoe extracts on immunocompetent cells in vitro and in vivo and their relevance for the therapy of tumor diseases and other clinical entities. In Scheer R et al.(Ed): Forschritte in der Mistletherapie. KVC Verlag, Essen, 207-221. 2005

  • Lagmay JP, Krailo MD, Dang H, Kim A, Hawkins DS, Beaty O 3rd, Widemann BC, Zwerdling T, Bomgaars L, Langevin AM, Grier HE, Weigel B, Blaney SM, Gorlick R, Janeway KA. Outcome of Patients With Recurrent Osteosarcoma Enrolled in Seven Phase II Trials Through Children's Cancer Group, Pediatric Oncology Group, and Children's Oncology Group: Learning From the Past to Move Forward. J Clin Oncol. 2016 Sep 1;34(25):3031-8. doi: 10.1200/JCO.2015.65.5381. Epub 2016 Jul 11.

    PubMed 27400942

  • Loef M, Walach H. Quality of life in cancer patients treated with mistletoe: a systematic review and meta-analysis. BMC Complement Med Ther. 2020 Jul 20;20(1):227. doi: 10.1186/s12906-020-03013-3.

    PubMed 32690087

  • Longhi A, Errani C, De Paolis M, Mercuri M, Bacci G. Primary bone osteosarcoma in the pediatric age: state of the art. Cancer Treat Rev. 2006 Oct;32(6):423-36. doi: 10.1016/j.ctrv.2006.05.005. Epub 2006 Jul 24.

    PubMed 16860938

  • Longhi A, Reif M, Mariani E, Ferrari S. A Randomized Study on Postrelapse Disease-Free Survival with Adjuvant Mistletoe versus Oral Etoposide in Osteosarcoma Patients. Evid Based Complement Alternat Med. 2014;2014:210198. doi: 10.1155/2014/210198. Epub 2014 Mar 31.

    PubMed 24803944

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iscador*P in people with Osteogenic Sarcoma Recurrent, run by Hackensack Meridian Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Goode, MS, RN, PCNS-BC (5519964995, laura.goode@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: 12-months post complete resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726383, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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