OsteosarcomaPhase 2NCT00572130
Phase II Study of Intravenous Rexin-G in Osteosarcoma
A Phase 2 study testing Rexin-G Dose 1 and Rexin-G Dose 2 in people with Osteosarcoma, run by Epeius Biotechnologies at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Rexin-G Dose 1 and Rexin-G Dose 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2011
- Phase
- Phase 2
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with recurrent or metastatic osteosarcoma who is considered refractory to known therapies.
- Histologically or cytologically confirmed osteosarcoma 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Epeius Clinical Research Unit/Sarcoma Oncology Center
Los Angeles, California, 91108
About this study
Official title: A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma
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.
Read the 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.
- Conditions
- Osteosarcoma
- Being tested
- Rexin-G Dose 1, Rexin-G Dose 2
- Keywords
- Tumor-targeted gene medicine, Cyclin G1 gene, Osteosarcoma
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rexin-G Dose 1Genetic
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
Rexin-G Dose 2Genetic
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
| Study group | Role | What they receive |
|---|---|---|
| Rexin-G Dose 1 | Experimental | Not described Receives: Genetic: Rexin-G Dose 1 |
| Rexin-G Dose 2 | Experimental | Not described Receives: Genetic: Rexin-G Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria
Measured: 12-18 months
Secondary outcomes (1)
Clinical efficacy as measured by progression-free survival greater than one month and over-all survival of 6 months or longer; clinical toxicity measures
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epeius Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sant P Chawla, M.D., Principal investigator, Epeius Clinical Research Unit/Sarcoma Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572130
- Sponsor's protocol ID
- C07-110
- Status last verified
- Feb 2010
- First submitted
- 10 Dec 2007
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intravenous Rexin-G in Recurrent or Metastatic Osteosarcoma
- ClinicalTrials.gov ID
- NCT00572130
- Acronym / sponsor ID
- C07-110
- Conditions
- Osteosarcoma
- Keywords
- Tumor-targeted gene medicine, Cyclin G1 gene, Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Epeius BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rexin-G Dose 1 | Experimental | Genetic: Rexin-G Dose 1 |
| Rexin-G Dose 2 | Experimental | Genetic: Rexin-G Dose 2 |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with recurrent or metastatic osteosarcoma who is considered refractory to known therapies.
- Histologically or cytologically confirmed osteosarcoma 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%
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rexin-G Dose 1Rexin-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 | Genetic | Rexin-G Dose 1 |
| Rexin-G Dose 2Rexin-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 | Genetic | Rexin-G Dose 2 |
Primary outcome
Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria
Time frame: 12-18 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Sponsor's Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sant P Chawla, M.D. principal investigator
Epeius Clinical Research Unit/Sarcoma Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rexin-G Dose 1 and Rexin-G Dose 2 in people with Osteosarcoma, run by Epeius Biotechnologies 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 12 inclusion and 6 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 10 Jun 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical efficacy as measured by over-all response rates (either CR, PR or SD) by International PET criteria (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2011.