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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoints: details revised at 2 of 2 entries
    • Study title expanded, about 1 word
    v20
  2. Re-verified, no change to tracked fieldsv19
  3. Site contacts updated at 1 of 2 sitesv18
  4. 3 versions Re-verified since Jul 2, 2024, no change to tracked fieldsv15-v17
  5. Start date changed from estimate of May 20, 2024 to May 14, 2024v14
Show 12 earlier versionsHide 12 earlier versions
  1. Start date: Apr 12, 2024 to May 20, 2024
    • Primary and study completion dates: Apr 11, 2027 to May 11, 2027
    v13
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 19, 2027 to Apr 11, 2027
    • Start date: Apr 20, 2024 to Apr 12, 2024
    • Site details revised at 2 of 2 sites
    v12
  3. Start date: Mar 20, 2024 to Apr 20, 2024
    • Primary and study completion dates: Mar 19, 2027 to Apr 19, 2027
    v11
  4. Primary and study completion dates: Mar 1, 2027 to Mar 19, 2027
    • Start date: Mar 15, 2024 to Mar 20, 2024
    v10
  5. Start date: Jan 15, 2024 to Mar 15, 2024
    • Primary and study completion dates: Jan 1, 2027 to Mar 1, 2027
    • Site contacts updated at 1 of 2 sites
    v9
  6. Start date: Dec 15, 2023 to Jan 15, 2024v8
  7. Re-verified, no change to tracked fieldsv7
  8. Start date: Oct 15, 2023 to Dec 15, 2023
    • Study title expanded, about 3 words
    v6
  9. Start date: Aug 15, 2023 to Oct 15, 2023v5
  10. Start date: Jun 15, 2023 to Aug 15, 2023v4
  11. Start date: Apr 15, 2023 to Jun 15, 2023v3
  12. Start date: Mar 1, 2023 to Apr 15, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05726383
Lead Sponsor Hackensack Meridian Health
Collaborators: M.D. Anderson Cancer Center, Iscador AG, Arlesheim, Switzerland., Tackle Kids Cancer, Susan Zabransky Hughes Foundation
Conditions
(from sponsor)		 Osteogenic Sarcoma Recurrent
Related terms Bone Neoplasms, Neoplasm Metastasis, Sarcoma
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov