Safety and Efficacy Study Using Rexin-G for Sarcoma - Full Text View

Sponsored by:	Epeius Biotechnologies
Information provided by:	Epeius Biotechnologies
ClinicalTrials.gov Identifier:	NCT00505713

Purpose

Rexin-G is a tumor-targeted (pathotropic or disease-seeking) nanoparticle that when injected intravenously, seeks out and accumulates in cancerous lesions, thus enhancing local drug concentration within tumors. The goal of the adaptive trial design is to confirm the over-all safety 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.

Condition	Intervention	Phase
Sarcoma	Genetic: Rexin-G	Phase I Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Safety and Efficacy of Rexin-G as Intervention for Recurrent or Metastatic Sarcoma

Further study details as provided by Epeius Biotechnologies:

Primary Outcome Measures:

Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To identify an objective tumor response to Rexin-G [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dose Level 1 of escalating doses of Rexin-G i.v.	Genetic: Rexin-G Dosing Schedule: 1 x 10e11 cfu two 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
3: Experimental Dose Level 3 of escalating doses of Rexin-G i.v.	Genetic: Rexin-G Dosing Schedule: 2 x 10e11 cfu i.v. three 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.
4: Experimental Dose Level 4 of escalating doses of Rexin-G i.v.	Genetic: Rexin-G Dosing Schedule: 3 x 10e11 cfu i.w. three 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.
5: Experimental Dose Level 5 of escalating doses of Rexin-G i.v.	Genetic: Rexin-G Dosing Schedule: 4 x 10e 11 cfu i.v. three 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.
2: Experimental Dose Level 2 of escalating doses of Rexin-G i.v.	Genetic: Rexin-G Dosing Schedule: 1 x 10e11 cfu i.v. three 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.

Detailed Description:

The Phase I/II clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible.

The goal of the adaptive trial design is to confirm the over-all safety 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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed recurrent or metastatic sarcoma 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.

Exclusion Criteria:

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.
Patient who do not meet the inclusion criteria.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505713

Locations

United States, California
Epeius Clinical Research Unit
San Marino, California, United States, 91108
Sarcoma Oncology Center
Santa Monica, California, United States, 90403

Sponsors and Collaborators

Epeius Biotechnologies

Investigators

Principal Investigator:

Sant P Chawla, M.D.

Epeius Clinical Research Unit/Sarcoma Oncology Center

More Information

No publications provided

Responsible Party:	Epeius Biotechnologies Corporation ( Erlinda M. Gordon, M.D. )
Study ID Numbers:	C07-103
Study First Received:	July 19, 2007
Last Updated:	October 5, 2008
ClinicalTrials.gov Identifier:	NCT00505713 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epeius Biotechnologies:

Sarcoma
Rexin-G
Gene Therapy

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma
Recurrence

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on May 06, 2009