BLESSED: Expanded Access for DeltaRex-G for Advanced Solid Tumors, Lymphoma and Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04091295|
Expanded Access Status : Temporarily not available
First Posted : September 16, 2019
Last Update Posted : December 26, 2019
|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 Chordoma All Solid Tumors||Drug: DeltaRex-G|
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 1.6 x 10e10 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.
|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|
- Drug: DeltaRex-G
Intravenous infusions of DeltaRex-G for treatment of advanced solid tumors, B cell lymphoma, and multiple myeloma that have failed standard therapiesOther Name: DeltaRex-G Retroviral Vector Encoding a Cyclin G1 Inhibitor
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
|United States, California|
|Sarcoma Oncology Research Center, LLC|
|Santa Monica, California, United States, 90403|
|Principal Investigator:||ERLINDA M GORDON, MD||Sarcoma Oncology Research Center, LLC|