27:I[164923,["/_next/static/immutable/chunks/0x-9rc1bm-510.js","/_next/static/immutable/chunks/0u73ovrok9bmr.js","/_next/static/immutable/chunks/3t9ifrnugpnlb.js","/_next/static/immutable/chunks/3gdp0tzp2t65u.js","/_next/static/immutable/chunks/0qexc5596g7lf.js","/_next/static/immutable/chunks/3nkl8euu6dycn.js","/_next/static/immutable/chunks/28p3k9kvs3dfa.js","/_next/static/immutable/chunks/04j_o97cgxn2x.js","/_next/static/immutable/chunks/18bybpoq919w1.js"],"ClinicalTrialDetail"] 28:T592,The p53 gene is a vital tumor suppressor gene in humans. Numerous human tumors possess a loss or mutation of wild type p53 (wtp53). In addition to playing a crucial role in cell cycle control, the p53 gene is a critical component in two of the pathways involved in regulating tumor cell growth: cell death (apoptosis) and the regulation of angiogenesis. The loss of such critical tumor suppressor activity is believed to be responsible for p53's involvement in such a broad array of human tumors and resistance to chemo/radiotherapy. SGT-53 is a complex composed of a wild type p53 gene (plasmid DNA) encapsulated in a liposome that is targeted to tumor cells by means of an anti-transferrin receptor single-chain antibody fragment (TfRscFv) attached to the outside of the liposome. Pre-clinical studies have indicated that SGT-53 could sensitize tumors to the effects of radiation/chemotherapy. The Phase 1a portion of this clinical study was designed to evaluate the safety and maximum tolerated dose (MTD) of SGT-53. In addition, pharmacokinetics of escalating doses of SGT-53 will be measured and correlated with tumor response and toxicity. The Phase Ib portion of this clinical study is designed to evaluate the safety of SGT-53 in combination with docetaxel, determine the recommended Phase II doses of these two agents, and evaluate the effect of the combination of SGT-53 and docetaxel on tumor size or progression.29:T11dd,Inclusion Criteria: * Have a biopsy confirmed diagnosis thereby providing histological diagnosis of a solid tumor malignancy. * Have been offered all standard or approved therapies for which they would be considered eligible and have specifically declined or decided to postpone. * Have solid tumors that can be measured on physical examination or by radiographic imaging studies. * Have a tumor for which docetaxel would be an appropriate therapeutic agent (Phase Ib only). * Patients (n=3) entered in phase Ib MTD dose expansion require biopsy accessible lesion in addition to measurable lesion and must consent to biopsy of tumor and normal skin. * Previous docetaxel allowed if \> 6 months prior to study entry (Phase Ib only). * Be 18 years old or older. * Have an ECOG performance study of 0, 1 or 2 for Phase Ia, 0-1 for Phase Ib. * Be able to give informed consent. * Have recovered from any previous therapy side effects or toxicities prior to initiating protocol study infusions. * Have a life expectancy of more than 12 weeks. * Female subjects of childbearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * Male and female subjects of reproductive potential must agree to use measures (e.g., condoms or birth control pills) to avoid pregnancy throughout the study and for 3 months following discontinuation of the study drug. * Organ function characterized by \/= 10.0 gm/dL * Absolute neutrophil count \> 1500/mm3 * White blood cell count \> 3000/mm3 * Platelet count \>/= 100,000/mm3 * PT/PTT \< 1.5 times the upper limit of normal * LDH \/= 50 ml/minute Exclusion Criteria: * Have hematological malignancy * Prior hypersensitivity reaction to docetaxel (Phase Ib only) * Are pregnant or lactating women * Have signs and symptoms consistent with an active infection * Fever (\> 38.1 C) * Treated with antibiotics for infection within one-week prior to study entry * Known HIV infection * Have any history of psychiatric disorders that would interfere with informed consent or follow-up. * Have any other concurrent disease that, in the judgment of the investigator, would contraindicate the administration of study drug or interfere with the study evaluations. * Have fasting glucose levels \>/= 180 mg/dL. * Have diastolic blood pressure of \> 90 mm Hg resting at baseline despite medication. (Acceptable if on hypertensive medication and diastolic blood pressure is \/= grade 2 based upon CTCAE v 3.0). * Requiring renal dialysis. * Receiving systemic steroids or other chronic immunosuppressive medications (e.g., tacrolimus, cyclosporine) within 30 days prior to study entry * Receiving hematopoietic growth factors * Receiving anticoagulants other than to maintain patency of venous access lines * Received an investigational drug within 30 days prior to study entry * Received radiation treatment \< 4 weeks prior to study entry * Had prior exposure to gene vector delivery products within the last 6 months * Received treatment with chemotherapeutic agents \< 4 weeks prior to study entry except for mitomycin C or nitrosurea where subjects who received mitomycin C or nitrosoureas \< 6 weeks prior to study entry are not eligible.25:["$","$L27",null,{"trial":{"nctId":"NCT00470613","briefTitle":"Safety Study of Infusion of SGT-53 to Treat Solid Tumors","officialTitle":"A Phase I Open-Label Safety and Pharmacokinetic Study of Escalating Doses of SGT-53 for Infusion in Subjects With Advanced Solid Tumors","briefSummary":"This is a Phase Ib study as a continuation of the original Phase I protocol. The purpose of this Phase Ib study is to evaluate the safety of a single course of SGT-53 in combination with docetaxel and determine the recommended Phase II doses of SGT-53 and docetaxel in combination for evaluation in subsequent clinical studies for the treatment of solid tumors.","detailedDescription":"$28","overallStatus":"COMPLETED","phase":"PHASE1","studyType":"INTERVENTIONAL","conditions":["Neoplasm"],"interventions":[{"type":"GENETIC","name":"SGT-53","description":"For Phase Ib: SGT-53 (2.4 mg DNA per infusion) will be administered in combination with docetaxel at 40 mg/m2 starting dose, cohort 1, cycle 1. SGT-53 will be administered weekly, on day 1 in weeks 2, 3, 5, and 6, and biweekly on days 1 and 4 in weeks 1, 4, and 7. Docetaxel will be administered every 3 weeks (weeks 1, 4, and 7)on day 3. Patients completing cohort 1, cycle 1 without DLT at 40 mg/m2 docetaxel will be allowed to dose escalate to 60 mg/m2 docetaxel in cycles 2 and 3.Cohort 2 (2.4mg DNA/infusion;75mg/m2 Docetaxel) will open 3 weeks after demonstration of 0/3 or ≤1/6 DLTs at docetaxel 60 mg/m2. Cohort 3 (3.6 mg DNA/infusion; 75 mg/m2 Docetaxel) will open after demonstration of 0/3 or ≤1/6 DLTs at SGT-53 2.4 mg DNA/infusion and docetaxel 75 mg/m2."}],"keywords":["Neoplasm"],"locations":[{"facility":"Mary Crowley Medical Research Center","city":"Dallas","state":"Texas","country":"United States","zip":"75201","lat":32.78306,"lng":-96.80667}],"eligibilityCriteria":"$29","minAge":18,"maxAge":null,"sex":"ALL","healthyVolunteers":false,"leadSponsor":"SynerGene Therapeutics, Inc.","collaborators":null,"contacts":null,"startDate":"$D2008-02-01T00:00:00.000Z","completionDate":"$D2016-12-01T00:00:00.000Z","primaryCompletionDate":"$D2016-12-01T00:00:00.000Z","firstPostDate":"$D2007-05-08T00:00:00.000Z","lastUpdatePostDate":"$D2017-04-26T00:00:00.000Z","enrollmentCount":25,"enrollmentType":"ACTUAL","aiSummary":"$undefined","aiSummaryGeneratedAt":null,"id":"$undefined","createdAt":"$undefined","updatedAt":"$undefined"}}]

What this study is about