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New treatment option for Osteogenic Sarcoma Recurrent
Official title Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
ClinicalTrials.gov ID: NCT05726383
What this study is testing
What is Iscador*P?
Iscador*P is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for osteogenic sarcoma recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 30
You may be able to join if
- 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...
- Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 8 weeks prior to study...
- Pathological confirmation of metastases from at least one of the resected sites.
- Age ≥ 8 years of age and \<30 years of age.
You likely can't join if
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the...
- 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...
- 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
See the full eligibility 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...
- 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...
- 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 \ 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 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.