Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 8 Years to 30 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests Iscador® P, a mistletoe treatment, for osteosarcoma, a type of bone cancer. It is for people ages 8 to 29 whose cancer came back in the lungs and whose visible cancer has all been removed by surgery. Patients receive shots under the skin and have CT scans to check if the cancer returns.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 8 to 29 and have osteosarcoma confirmed by a tissue test.
- Have had cancer return in the lungs at least once, with spread confirmed by testing tissue from at least one removed site.
- Have all visible cancer and suspected lung cancer sites removed within 8 weeks before joining. Tiny cancer cells at the edge of removed tissue do not rule you out.
- Be able to receive shots under the skin and meet the study’s daily activity score of at least 60%.
- Be expected to live more than 2 months.
- Have recovered from past cancer treatment and major surgery. Some lasting hair loss, low blood counts, or nerve problems are allowed.
- Meet the study’s blood count, liver, and kidney test limits.
- If able to become pregnant, have the required negative pregnancy tests and use effective birth control during treatment and for 120 days afterward. Male patients must also use birth control from the first dose through 120 days after the last dose.
Who can't join
- Have a condition, treatment, or test result that the study doctor thinks could make joining unsafe or affect the results. This includes an infection needing treatment throughout the body, cancer in the brain or spinal cord area, or a new osteosarcoma return outside the lungs.
- Have another cancer that is growing or needs treatment, or had another cancer in the past 5 years. Exceptions include certain fully treated skin cancers and early or precancerous changes in the cervix.
- Have a mental health or substance use disorder that would prevent you from following study requirements.
- Be receiving another study treatment, or have received an experimental drug or used an experimental device within 4 weeks before the first dose.
- Have HIV or active hepatitis B or C, which are liver infections. Past hepatitis B or a positive hepatitis C antibody test may be allowed with further virus testing.
- Have certain long-term immune diseases, active autoimmune disease, a disease treated with immune-suppressing drugs, an overactive thyroid with a fast heartbeat, tuberculosis, a parasite infection, or Crohn’s disease.
- Be pregnant or breastfeeding, or have a known allergy to Iscador® P or another Viscum album mistletoe product.
- Have had chemotherapy or immune treatment within 3 weeks, or radiation within 2 weeks, before joining. You cannot receive extra chemotherapy or drugs that boost or suppress the immune system during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. * 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 1. 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 2. Absolute neutrophil count ≥ 500/dL 3. Platelet count ≥ 20,000/L 4. Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance (CrCl) ≥ 60 ml/minute Exclusion Criteria: * 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 * 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.
Study sites (2)
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601Laura Goode, MS, RN, PCNS-BC · Study contact · 5519964995 · laura.goode@hmhn.orgKatharine Offer, MD · Principal investigatorMore trials in Hackensack
TX
- M.D. Anderson Children's Cancer Hospital · Houston, TX 77030Karen Moody, MD · Study contact · 713-792-2260 · kmoody@mdanderson.orgKaren Moody, MD · Principal investigatorMore trials in Houston