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

NCT00470613 | Completed Phase 1 DMC

• 1 other identifier: SGT53-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasm

Keywords

Neoplasm

Outcome Measures

Primary Outcomes (1)

• Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations.

  7 weeks

Secondary Outcomes (3)

• Pharmacokinetic parameters

  6 weeks

• Tumor Response

  Week 6 for Phase Ia, and weeks 9 for Phase Ib

• Determine the presence of exogenous wtp53 in tumor

  Week 5 or Week 6

Study Arms (1)

SGT-53

EXPERIMENTAL

SGT-53 (2.4mg DNA/infusion) will be administered in a standard 3x3 dose escalation design in combination with docetaxel 40mg/m2 starting dose, cohort 1, cycle 1. This protocol will allow for both inter- and intra-patient dose escalations. SGT-53 will be administered weekly, day 1 except weeks 1, 4 \& 7 when it will be administered biweekly on days 1 \& 4. Docetaxel will be administered every 3 weeks (weeks 1, 4 \& 7) on day 3. Patients completing cohort 1, cycle 1 without DLT at docetaxel 40mg/m2 will be allowed to dose escalate to 60mg/m2 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 60mg/m2. Cohort 3 (3.6mg DNA/infusion; 75mg/m2 Docetaxel) will open after demonstration of 0/3 or ≤1/6 DLTs at SGT-53 2.4mg DNA/infusion and docetaxel 75mg/m2. If necessary, the dose of docetaxel in cycle 2 and 3 may be reduced to 60mg/m2.

Genetic: SGT-53

Interventions

SGT-53 GENETIC

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.

SGT-53

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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

Sponsors & Collaborators

• SynerGene Therapeutics, Inc.: lead

Study Sites (1)

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• John J. Nemunaitis, MD

  Mary Crowley Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 8, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

US (1)