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BLESSED: Expanded Access for DeltaRex-G for Advanced Solid Tumors, Lymphoma and Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT04091295
Expanded Access Status : Temporarily not available
First Posted : September 16, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Erlinda M Gordon, Aveni Foundation

Brief Summary:
Twenty to forty patients will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 5.3 x 10e9 Neo Units (60 ml) 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
Pancreatic Adenocarcinoma Osteosarcoma MPNST (Malignant Peripheral Nerve Sheath Tumor) Chondrosarcoma Soft Tissue Sarcoma Glioblastoma Carcinoma of Breast Lymphoma Multiple Myeloma Gall Bladder Cancer Drug: DeltaRex-G

Detailed Description:

Twenty to forty patients with advanced solid malignancies will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 5.3 x 10e9 Neo Units (60 ml) 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.


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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: BLESSED: Expanded Access for DeltaRex-G for Advanced Solid Tumors, Lymphoma and Multiple Myeloma



Intervention Details:
  • Drug: DeltaRex-G
    Intravenous infusions of DeltaRex-G for treatment of advanced solid tumors, B cell lymphoma, and multiple myeloma that have failed standard therapies
    Other Name: DeltaRex-G Retroviral Vector Encoding a Cyclin G1 Inhibitor

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with confirmed diagnosis of advanced solid tumor, lymphoma or multiple myeloma

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091295


Locations
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United States, California
Sarcoma Oncology Research Center, LLC
Santa Monica, California, United States, 90403
Sponsors and Collaborators
Aveni Foundation
Investigators
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Principal Investigator: ERLINDA M GORDON, MD Sarcoma Oncology Research Center, LLC

Publications of Results:
Other Publications:
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Responsible Party: Erlinda M Gordon, Chief Medical Officer, Aveni Foundation
ClinicalTrials.gov Identifier: NCT04091295     History of Changes
Other Study ID Numbers: AF19-200
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Erlinda M Gordon, Aveni Foundation:
tumor targeted gene therapy
human cyclin G1 inhibitor
cell cycle control
CCNG1 inhibitor
Additional relevant MeSH terms:
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Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Sarcoma
Glioblastoma
Osteosarcoma
Chondrosarcoma
Nerve Sheath Neoplasms
Neurofibrosarcoma
Breast Neoplasms
Gallbladder Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplasms, Glandular and Epithelial
Neoplasms, Connective and Soft Tissue
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors