NCT00504998

Brief Summary

The goal of the adaptive trial design is to determine the over-all safety of escalating doses of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jul 2007

Typical duration for phase_1 pancreatic-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 10, 2011

Status Verified

February 1, 2010

Enrollment Period

3 years

First QC Date

July 18, 2007

Last Update Submit

June 9, 2011

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerRexin-GTreatment

Outcome Measures

Primary Outcomes (1)

  • Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles.

    24

Secondary Outcomes (1)

  • To identify an objective tumor response to Rexin-G

    24 months

Study Arms (5)

1

EXPERIMENTAL

Dose Level 1 of escalating doses of Rexin-G i.v.

Genetic: Rexin-G

2

EXPERIMENTAL

Dose Level 2 of escalating doses of Rexin-G i.v.

Genetic: Rexin-G

3

EXPERIMENTAL

Dose Level 3 of escalating doses of Rexin-G i.v.

Genetic: Rexin-G

4

EXPERIMENTAL

Dose Level 4 of escalating doses of Rexin-G i.v.

Genetic: Rexin-G

5

EXPERIMENTAL

Dose Level 5 of escalating doses of Rexin-G i.v.

Genetic: Rexin-G

Interventions

Rexin-GGENETIC

Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed recurrent or metastatic pancreatic cancer that has failed gemcitabine and that is measurable.
  • Adequate hepatic function: Total bilirubin \< 2.0 mg/dL (upper limit included); AST/ALT \< 2x institutional norm; alkaline phosphatase \< 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin \> 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits.
  • Performance status must be \< 1 (ECOG 0-1) with a life expectancy of at least 3 months.
  • Hemoglobin \> 9 gms%
  • Absolute granulocyte count \> 1000/uL, and platelet count \> 100,000/uL.
  • Serum creatinine of less than 1.5 mg%.
  • There must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
  • Accessibility of peripheral or central IV line
  • Age \> 10 years
  • Patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to Grade 1 or less toxicity.
  • The ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years.
  • Woman who are pregnant or nursing
  • Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception.
  • Patients who are transfusion dependent (more than one transfusion per month)
  • Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Epeius Clinical Research Unit

San Marino, California, 91108, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Bruckner Oncology

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

retrovector encoding mutant anti-cyclin G1

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Sant P Chawla, M.D.

    Epeius Clinical Research Unit/Sarcoma Oncology Center

    PRINCIPAL INVESTIGATOR

  • Howard W Bruckner, M.D.

    Bruckner Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 20, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2010

Study Completion

June 1, 2011

Last Updated

June 10, 2011

Record last verified: 2010-02

Locations

US(3)