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Phase II Study of Intravenous Rexin-G in Osteosarcoma

This study has been completed.
Sponsor:
Information provided by:
Epeius Biotechnologies
ClinicalTrials.gov Identifier:
NCT00572130
First received: December 10, 2007
Last updated: June 9, 2011
Last verified: February 2010
History of Changes
  Purpose

Rexin-G is a tumor-targeted gene medicine that is designed to seek out and destroy both primary tumors and metastatic cancers without the side effects of standard chemotherapy. The objectives of the study are: (1) to evaluate the clinical effectiveness of intravenous injections of Rexin-G, a tumor-targeted gene vector, in controlling tumor growth and prolonging life, and (2) to evaluate its over-all safety.


Condition Intervention Phase
Osteosarcoma
 Genetic: Rexin-G Dose 1
Genetic: Rexin-G Dose 2
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Epeius Biotechnologies:

Primary Outcome Measures:
  • Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical efficacy as measured by progression-free survival greater than one month and over-all survival of 6 months or longer; clinical toxicity measures [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rexin-G Dose 1 Genetic: Rexin-G Dose 1
Rexin-G i.v., 1 x 10e11 cfu, two times a week x 4 weeks, rest 2 weeks May be repeated if grade 1 or less toxicity
Experimental: Rexin-G Dose 2 Genetic: Rexin-G Dose 2
Rexin-G i.v., 1 x 10e11 cfu, three times a week x 4 weeks; rest 2 weeks May repeated if grade 1 or less toxicity

Detailed Description:

The adaptive trial design of this advanced Phase II study incorporates (i) a dosing schedule based on the patient's estimated tumor burden and not on standard dosing per kilogram body weight or body surface area, and (2) a tumor response evaluation process that is unique to the manner in which osteosarcoma responds favorably to therapy, i.e., with necrosis and increasing calcification in metastatic tumors and decreased glucose utilization using PET-CT imaging studies.

Twenty to thirty patients will receive Rexin-G at either Dose Level 1 or 2. Patients will be assigned a dose level based on the estimated tumor burden as measured by PET-CT imaging studies. Estimated tumor burden is measured by multiplying the sum of the longest diameters of target lesions in cm by 10e9 cancer cells. If the tumor burden is less than 10 billion cells, the patient will be assigned to Dose Level 1, if the tumor burden is greater than 10 billion cells, the patient will be assigned to Dose Level 2.

*Treatment Cycle Dose Level Vector Dose/Day Max.Volume/Dose

Two times a week 1 1.0 x 10e11 cfu 200 ml

Three times a week 2 1.0 x 10e11 cfu 200 ml

* Each treatment cycle will be six weeks (four weeks of treatment and two weeks of rest). Patients who have resolution of toxicity to < grade I may have repeat cycles. After one or more treatment cycles, the principal investigator may recommend surgical debulking or complete surgical removal. If residual disease is present either by histopathological examination or by PET-CT scan, repeat treatment cycles may be given 3-4 weeks after surgery, if the surgical incision has healed, and if the patient has < grade I toxicity.

  Eligibility

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

Inclusion Criteria:

  1. Patient with recurrent or metastatic osteosarcoma who is considered refractory to known therapies.
  2. Histologically or cytologically confirmed osteosarcoma that is measurable.
  3. 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.
  4. Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
  5. Hemoglobin > 9 gms%
  6. Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
  7. Serum creatinine of less than 1.5 mg%.
  8. 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.
  9. Accessibility of peripheral or central IV line
  10. Age > 10 years
  11. 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.
  12. The ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. 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.
  2. Woman who are pregnant or nursing
  3. 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.
  4. Patients who are transfusion dependent (more than one transfusion per month)
  5. Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
  6. Patient who do not meet the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572130

Locations
United States, California
Epeius Clinical Research Unit/Sarcoma Oncology Center
Los Angeles, California, United States, 91108
Sponsors and Collaborators
Epeius Biotechnologies
Investigators
Principal Investigator: Sant P Chawla, M.D. Epeius Clinical Research Unit/Sarcoma Oncology Center
  More Information

Additional Information:
Sponsor's Official Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Erlinda M. Gordon, M.D., Epeius Biotechnologies Corporation
ClinicalTrials.gov Identifier: NCT00572130     History of Changes
Other Study ID Numbers: C07-110
Study First Received: December 10, 2007
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Epeius Biotechnologies:
Tumor-targeted gene medicine
Cyclin G1 gene
Osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on May 16, 2013