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Cancer Vaccine
Mistletoe Immunotherapy for Osteosarcoma
Phase 2
Recruiting
Led By Katharine Offer, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months post complete resection of all metastases
Awards & highlights
Summary
This trial is to test a possible cancer treatment for patients with osteosarcoma who had surgery to remove all gross disease from their lungs. It involves using Iscador® P at different concentrations and monitoring with CT scans.
Who is the study for?
This trial is for osteosarcoma patients aged 8-30 who've had lung metastases surgically removed and are in at least their second complete remission. They must be able to handle subcutaneous injections, have a certain level of physical ability, adequate organ function, no active infections or other cancers, not pregnant or breastfeeding, and agree to use contraception.
What is being tested?
The study tests Iscador® P immunotherapy on patients with recurrent osteogenic sarcoma after pulmonary metastases resection. It's a phase II trial where participants receive the manufacturer-recommended maximum tolerated dose (MTD) of Iscador® P with regular CT scans to monitor relapse.
What are the potential side effects?
While specific side effects for Iscador® P aren't listed here, similar immunotherapies can cause injection site reactions, flu-like symptoms such as fever and chills, gastrointestinal issues like nausea or diarrhea, fatigue and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months post complete resection of all metastases
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months post complete resection of all metastases
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event Free Survival
Secondary study objectives
Quality of life post resection
Time to relapse
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment Arm - Iscador*PExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Susan Zabransky Hughes FoundationUNKNOWN
Hackensack Meridian HealthLead Sponsor
134 Previous Clinical Trials
29,891 Total Patients Enrolled
Iscador AG, Arlesheim, Switzerland.UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiation therapy within the last two weeks.I have recently undergone chemotherapy or immunotherapy.I am allergic to Iscador® P or similar products.I have another cancer besides osteosarcoma that is getting worse or needs treatment.I am currently on medication for an infection.I have active brain metastases or cancer in the lining of my brain.I haven't had cancer in the last 5 years, except for specific skin or cervical conditions.I have a history of certain immune or infectious diseases, or Crohn's disease.I am taking another chemotherapy drug during this study.I am not taking any drugs that affect my immune system.Side effects from my last cancer treatment have mostly gone away.I am mostly able to care for myself and carry out daily activities.I am between 8 and 29 years old.I have been diagnosed with osteosarcoma.I have a history of HIV or active hepatitis B/C.My osteosarcoma has returned in a place other than my lung.My liver, white blood cells, platelets, and kidney functions are within normal ranges.I agree to use effective birth control.My cancer returned in the lung after surgery to remove all visible signs of it.I had surgery to remove lung metastases within the last 8 weeks.I can receive shots under my skin.My cancer spread has been confirmed by lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm - Iscador*P
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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