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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post complete resection of all metastases for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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