Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma

Conditions

• Osteogenic Sarcoma Recurrent

Eligibility Criteria

Sex

ALL

Age

8 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Iscador*P — DRUG
  Iscador P given for 2 cycles with follow up imaging done every 2 cycles. If imaging is negative patient remains on study for 13 cycles. If new lesion is found, then patient is off study.

Study Details

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.

Key Dates

Start date

May 14, 2024

Status verified

May 2026

Primary completion

May 11, 2027

Completion

May 11, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm - Iscador*P
  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.

Primary Outcome Measure

Event Free Survival [ Time Frame: 12-months post complete resection ]

Central Contacts

• Laura Goode, MS, RN, PCNS-BC
  5519964995
  [email protected]

Locations (2)

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