Expanded Access for DeltaRex-G for Advanced Solid Tumors, B Cell Lymphoma and Multiple Myeloma
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.
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 Advanced Solid Tumors DeltaRex-G Sarcoma Oncology Research Center, LLC Temporarily not available Aveni Foundation Published on BioPortfolio: 2019-09-20T03:46:41-0400 Phase I Study of SHR7390 in Patients With Advanced Solid Tumors This aim of study to assess the safety and tolerability of SHR7390 and to define the maximum
tolerated dose (MTD) of SHR7390 in the patients with advanced solid tumors.
To evaluate the ph... This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with
advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid
tumors... The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable
when given as weekly infusions to adult patients with advanced solid tumors. A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors This is an open label, single arm, dose escalation study of ARQ 197 in patients with
advanced solid tumors. A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of
orally administered SL-801 in patients with Advanced Solid Tumors Epigenetic abnormalities are manifold in all solid tumors and include changes in chromatin configuration and DNA methylation. The authors designed a phase 1 study to evaluate the oral DNA methyltransf... To characterize the effect of erdafitinib on electrocardiogram (ECG) parameters and the relationship between erdafitinib plasma concentrations and QTc interval changes in patients with advanced or ref... The reported maximum tolerated dose (MTD) of single-agent belinostat is 1000 mg/m given days 1-5, every 21 days. Pre-clinical evidence suggests histone deacetylase inhibitors enhance retinoic acid s... In vitro data showed that talazoparib is a substrate for P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters. This open-label, two-arm, drug-drug interaction Phase 1 study i... Vactosertib, a novel inhibitor of transforming growth factor-β type Ι receptor, is under development for the treatment of various cancers. The objective of this study was to characterize the populat... Lomustine An alkylating agent of value against both hematologic malignancies and solid tumors. Response Evaluation Criteria In Solid Tumors An internationally recognized set of published rules used for evaluation of cancer treatment that define when tumors found in cancer patients improve, worsen, or remain stable during treatment. These criteria are based specifically on the response of the tumor(s) to treatment, and not on the overall health status of the patient resulting from treatment. Brenner Tumor A smooth, solid or cystic fibroepithelial (FIBROEPITHELIAL NEOPLASMS) tumor, usually found in the OVARIES but can also be found in the adnexal region and the KIDNEYS. It consists of a fibrous stroma with nests of epithelial cells that sometimes resemble the transitional cells lining the urinary bladder. Brenner tumors generally are benign and asymptomatic. Malignant Brenner tumors have been reported. Bleomycin A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2. It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors. Lymphoma, Aids-related B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.Study Design
Conditions
Intervention
Location
Santa Monica
California
United States
90403Status
Source
Results (where available)
Links
Clinical Trials
PubMed Articles
Medical and Biotech [MESH] Definitions
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