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NeoplasmPhase 1NCT00470613

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

A Phase 1 study testing SGT-53 in people with Neoplasm, run by SynerGene Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm
What is being tested?
SGT-53
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Feb 2008to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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
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  • 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
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75201

Other trials in United States

About this study

Official title: A Phase I Open-Label Safety and Pharmacokinetic Study of Escalating Doses of SGT-53 for Infusion in Subjects With Advanced Solid Tumors

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.

Read the detailed description

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.

Conditions
Neoplasm
Being tested
SGT-53
Keywords
Neoplasm
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGT-53Genetic

    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.

Study groups in NCT00470613
Study groupRoleWhat they receive
SGT-53ExperimentalSGT-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.
Receives: Genetic: SGT-53

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 7 weeks

Secondary outcomes (3)

  1. Pharmacokinetic parameters

    Phase Ia Only

    Measured: 6 weeks

  2. Tumor Response

    Assessed by physical measurements or by radiographic modalities

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

  3. Determine the presence of exogenous wtp53 in tumor

    Measured: Week 5 or Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470613
Sponsor's protocol ID
SGT53-01
Status last verified
Apr 2017
First submitted
4 May 2007
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SGT-53 in people with Neoplasm, run by SynerGene Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety will be assessed by analysis of adverse experiences, clinical laboratory tests, and physical examinations. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.

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