Study on Mistletoe Immunotherapy for Recurrent Osteogenic Sarcoma

Sponsor: Hackensack Meridian Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05726383

Provider View

This clinical trial is testing a mistletoe-based treatment called Iscador® P for patients with osteosarcoma that has returned in the lungs after surgery. The study aims to see if this treatment can help prevent the cancer from coming back.

Patient Parameters

Program Overview

This study is for patients with osteosarcoma, a type of bone cancer, that has returned in the lungs after surgery. The treatment involves using a mistletoe extract called Iscador® P, which is already used in some countries for treating solid tumors. Patients will receive this treatment through injections and will have regular CT scans to check for any signs of the cancer returning.

Description

In this study, patients with osteosarcoma that has come back in the lungs after surgery will receive a treatment called Iscador® P. This treatment is given as an injection under the skin three times a week. The treatment starts with a low dose and gradually increases if the patient tolerates it well. The study will last for about a year, during which patients will have regular scans to monitor their health.

The study is open to patients who have had surgery to remove all visible cancer in the lungs and are in good health. Participants must be able to receive injections and agree to regular monitoring. The study aims to see if Iscador® P can help prevent the cancer from returning.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with osteosarcoma.
  • Cancer has returned in the lungs after surgery to remove all visible tumors.
  • Surgery to remove lung tumors was completed within 8 weeks before joining the study.
  • Aged between 8 and 30 years old.
  • Able to receive injections under the skin.
  • In good overall health, with a performance status score of 60% or higher.
  • Women of childbearing age must have a negative pregnancy test and agree to use contraception during the study and for 120 days after.
  • Men must agree to use contraception during the study and for 120 days after.
  • Life expectancy of more than two months.
  • Recovered from any side effects of previous cancer treatments.
  • Meet specific blood test criteria for liver and kidney function, blood cell counts, and other health indicators.

Exclusion Criteria

  • Have another type of cancer that is progressing or needs treatment.
  • Have had another cancer within the last 5 years, except for certain skin or cervical cancers.
  • Have an active infection that requires treatment.
  • Have cancer that has spread to the brain or spinal cord.
  • Have a new recurrence of osteosarcoma outside the lungs.
  • Have psychiatric or substance abuse issues that would interfere with the study.
  • Are currently in another clinical trial or have been in one within the last 4 weeks.
  • Have a history of HIV or active hepatitis B or C infections.
  • Have certain immune system disorders or other specific health conditions.
  • Are pregnant or breastfeeding.
  • Have had chemotherapy or immunotherapy in the last three weeks.
  • Have had radiation therapy in the last two weeks.
  • Have an allergy to Iscador® P or similar products.
  • Are taking other immune system drugs.

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