The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.
To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies
To determine the recommended Phase 2 dose of paclitaxel as Oraxol
To determine the safety and tolerability of paclitaxel as Oraxol
To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol
To evaluate the tumor response
While radiation is an essential component to the treatment of glioblastoma, it's use is limited due to toxicity when higher doses are attempted. Rhenium is a compund which releases radiation in small particles that are absorbed after only a fraction of an inch. This limited penetration means that high doses potentially can be given without the toxicity of other forms of radiation. In order for the radiaiton to be retained within the tumor, it has been packaged in microscopic fat like particles termed nanoliposomes. These facilitate the uptake of the radiation particles by the tumor. In order to better characterize this form of radiation therapy, it is being administered in patients who have failed other forms of therapy for glioblastoma. The treatment is administered by tubing inserted into the center of the tumor in the operating room. There are two portionms to this study. The first involves progressively increasing doses until the most tolerable dose can be identified. The second portion of the study involves a larger number of patients being treated at the determined most tolerable dose to better evalaute how well the treatment works.
Assess the impact of dietary (omega 3 FFA) or pharmacological (ASA) COX-2 inhibitors on:
patient serum-induced expression of PGE2 and aromatase by neoplastic mammary epithelial cells
circulating levels of pro-inflammatory cytokines (i.e. IL-6, TNF-¿, IGF-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 PUFAs)
Correlation for body mass index impact on response to COX2 inhibition.
Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of ADCT-301 in patients with relapsed/refractory lymphoma
Determine the recommended dose of ADCT-301 for Part 2 (expansion).
Evaluate the activity of ADCT-301 measured by overall response rate, duration of response, progression-free survival, and overall survival.
Characterize the pharmacokinetic (PK) profile of HuMax-TAC (total antibody; drug-to-antibody ratio [DAR] ¿0), PBD-conjugated HuMax-TAC (DAR ¿1), and free warhead SG3199.
Evaluate anti-drug antibodies (ADAs) in blood before, during, and after treatment with ADCT-301.
Evaluate the pharmacodynamic (PD) profile of ADCT-301 as measured by correlation between clinical activity and CD25 expression level in tumor tissue, soluble CD25, and DNA cross-links in blood.
Evaluate the PK and PD relationship of ADCT-301.
Evaluate the change in white blood cell populations (such as activated T -cells) before, during, and after treatment with ADCT-301 (Part 2 only).
Explore the ADCT-301 and free warhead SG3199 concentration-QTc interval relationship.