BLESSED: Expanded Access for DeltaRex-G for Advanced Pancreatic Cancer and Sarcoma
Study Details
Study Description
Brief Summary
Twenty to forty patients will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 1.6 x 10e10 Neo Units per dose three times a week for 3 weeks followed by one week rest. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Twenty to forty patients with advanced pancreatic cancer and sarcoma will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 1.6 x 10e10 Neo Units per dose three times a week for 3 weeks followed by one week rest. 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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is ≥10 years of age, either male or female.
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Patient has advanced metastatic pancreatic cancer or advanced metastatic sarcoma confirmed by pathologic examination at diagnosis.
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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 ; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.
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Patient is able to understand or is willing to sign a written informed consent.
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Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion
Exclusion Criteria:
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Patient is unwilling to provide formal informed consent.
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Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarcoma Oncology Research Center, LLC | Santa Monica | California | United States | 90403 |
Sponsors and Collaborators
- Aveni Foundation
Investigators
- Principal Investigator: ERLINDA M GORDON, MD, Sarcoma Oncology Research Center, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- Al-Shihabi A, Chawla SP, Hall FL, Gordon EM. Exploiting Oncogenic Drivers along the CCNG1 Pathway for Cancer Therapy and Gene Therapy. Mol Ther Oncolytics. 2018 Dec 12;11:122-126. doi: 10.1016/j.omto.2018.11.002. eCollection 2018 Dec 21. Review.
- Chawla SP, Bruckner H, Morse MA, Assudani N, Hall FL, Gordon EM. A Phase I-II Study Using Rexin-G Tumor-Targeted Retrovector Encoding a Dominant-Negative Cyclin G1 Inhibitor for Advanced Pancreatic Cancer. Mol Ther Oncolytics. 2018 Dec 14;12:56-67. doi: 10.1016/j.omto.2018.12.005. eCollection 2019 Mar 29.
- Chawla SP, Chawla NS, Quon D, Chua-Alcala V, Blackwelder WC, Hall FL and Gordon EM: An advanced phase 1/2 study using an XC-targeted gene therapy vector for chemotherapy resistant sarcoma. Sarcoma Res Int 3: 1024, 2016
- Chawla SP, Chua VS, Fernandez L, Quon D, Saralou A, Blackwelder WC, Hall FL, Gordon EM. Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma. Mol Ther. 2009 Sep;17(9):1651-7. doi: 10.1038/mt.2009.126. Epub 2009 Jun 16.
- Gordon EM, Hall FL. Rexin-G, a targeted genetic medicine for cancer. Expert Opin Biol Ther. 2010 May;10(5):819-32. doi: 10.1517/14712598.2010.481666. Review.
- AF19-200