Expanded Access for DeltaRex-G for Osteosarcoma, Chondrosarcoma, Soft Tissue Sarcoma, Pancreas and Breast Cancer

February 28, 2024 updated by: Erlinda M Gordon, Aveni Foundation

BLESSED: Expanded Access for DeltaRex-G for Osteosarcoma, Chondrosarcoma, Soft Tissue Sarcoma, Pancreatic Cancer, and Carcinoma of Breast

Forty patients with osteosarcoma, chondrosarcoma, soft tissue sarcoma, pancreas and breast cancer will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one to three times a week. DeltaRex-G may be given alone or with one or more FDA approved cancer therapies/immunotherapies.

Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Detailed Description

Enhanced CCNG1 expression has been found in all cancer types tested at the Cancer Center of Southern California as of June 2023. Hence, in July 2023, the USFDA authorized the use of DeltaRex-G, a CCNG1 inhibitor, as platform therapy upon which one or more FDA approved cancer drugs/immunotherapies may be added. This would allow a personalized approach in the treatment of patients with advanced cancer who have failed standard therapies.

Forty patients with osteosarcoma, chondrosarcoma, soft tissue sarcoma, pancreas and breast cancer will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one-three times a week. DeltaRex-G may be given alone or with an FDA approved cancer therapy/immunotherapy on physician discretion.

Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

If the patient develops a treatment-related >Grade 3 adverse event, the DeltaRex-G infusions will be held and the patient will be monitored until the toxicity has resolved to <Grade 1, and the patient is stable, after which treatment may be resumed. If the adverse event does not resolve to <Grade 1 within 3 weeks, the DeltaRex-G treatment will be held until the data are discussed with the Food and Drug Administration and a decision is made whether to continue or terminate the study.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • Available
        • Sarcoma Oncology Research Center, LLC
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sant P Chawla, MD
        • Sub-Investigator:
          • Steven Wong, MD
        • Sub-Investigator:
          • Doris Quon, MD
        • Sub-Investigator:
          • Ania M Moradkhani, NP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 98 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is ≥12 years of age, either male or female for patients with sarcoma; >18 years of age, either male or female for pancreatic cancer and carcinoma of breast.
  • Patient has advanced metastatic pancreatic cancer or advanced metastatic sarcoma confirmed by pathologic examination at diagnosis.
  • Patients with advanced metastatic pancreatic cancer who have received systemic therapies such as FOLFIRINOX and gemcitabine + albumin-bound paclitaxel; patients with metastatic sarcoma who have disease progression after two or more lines of systemic treatments and not amenable to surgical resection or radiotherapy; specifically for osteosarcoma: have disease progression after high dose methotrexate, cisplatinum, doxorubicin and ifosfamide; for soft tissue sarcoma: have disease progression after doxorubicin + ifosfamide/mesna, gemcitabine, docetaxel, dacarbazine, trabectedin, pazopanib, eribulin; patients with metastatic carcinoma of breast who have disease progression with standard therapy (ACT), targeted therapies including aromatase inhibitors, trastuzumab, pertuzumab, enhertu, tyrosine kinase inhibitors, immune checkpoint inhibitors; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.
  • Patient is able to understand or is willing to sign a written informed consent.
  • Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion

Exclusion Criteria:

  • Patient is unwilling to provide formal informed consent.
  • Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveni Foundation

Investigators

  • Principal Investigator: ERLINDA M GORDON, MD, Sarcoma Oncology Research Center, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF19-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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