Safety Study of Infusion of SGT-53 to Treat Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasm

In brief

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.

Key facts

Study ID

NCT00470613

Run by

SynerGene Therapeutics, Inc.

People needed

25

Starts

2008-02-01

Expected to finish

2016-12-01

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 </= Grade 1 scores defined by CTCAE v3.0 unless, at the discretion of the investigator, the condition is not deemed to cause unacceptable risk to the patient. If deemed not to cause unacceptable risk to the patient, organ function of grade 2 is acceptable.
• Laboratory values meeting the following criteria:
• Hemoglobin >/= 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 </= 3 times the upper limit of normal and without clinical or laboratory evidence of DIC as determined by the clinical investigator
• Total bilirubin </= 1.5 times the upper limit of normal (unless elevation is known to be due to Gilbert's Disease)
• AST and ALT < 2.5 times the upper limit of normal withALP </= 2.5 x ULN
• Creatinine </= 1.5 mg/dL or creatinine clearance >/= 50 ml/minute

You may not qualify if…

• 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 </= 90 mm Hg.)
• Have an abnormal stress echo or unfavorable results (at the discretion of the cardiologist) from the cardiac consultation and evaluation.
• Have known cardiac disease, or a history of cardiac disease.
• Had within six months prior to enrollment any of the following:
• Cerebrovascular accident
• Uncontrolled congestive heart failure (dyspnea on minimal exertion or while supine)
• Unstable angina (chest pain greater than three times weekly while on therapy)
• Have significant baseline neuropathies (>/= 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

Where it is running

• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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