OsteosarcomaPhase 2NCT00504140
Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma
A Phase 2 study testing Etoposide and Interferon Alpha in people with Osteosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma. 2. To determine if IFN alters the plasma pharmacokinetics of etoposide. 3. To determine the toxicities of IFN and etoposide when administered together. 4. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Etoposide and Interferon Alpha
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1996to Mar 2009
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.
- Age 5-70 years.
- Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to 2.
- Patients must have measurable disease.
- Adequate hematologic, coagulation, renal, and hepatic function.
- No chemotherapy, immunotherapy, hormonal therapy or radiation therapy within 3 weeks of study entry.
Who cannot join
- Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
- Pregnant or lactating women.
- Patients who have had more than one prior biologic response modifier.
- Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
- Patients of childbearing potential, not practicing adequate contraception.
- Significant cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
Primary Objectives:
- To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
- To determine if IFN alters the plasma pharmacokinetics of etoposide.
- To determine the toxicities of IFN and etoposide when administered together.
- To determine IFN blood levels following combination therapy.
Read the detailed description
Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks (8 courses). The catheter will remain in place throughout treatment.
Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.
Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.
The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.
During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.
About 37 patients will be treated on the study at M. D. Anderson.
THIS IS AN INVESTIGATIONAL STUDY. IFN- and VP-16 are approved by the U.S. Food and Drug Administration for treating some types of cancer. Their use together against osteosarcoma is investigational.
- Conditions
- Osteosarcoma
- Being tested
- Etoposide, Interferon Alpha
- Keywords
- Osteosarcoma, Interferon Alpha, IFN-, Roferon, Recombinant Interferon Alpha, Etoposide, VP-16
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called VP-16
100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.
Interferon AlphaDrug
Also called IFN-, Roferon
5x10^6 mu/m^2 Subcutaneously Daily for 5 Days
| Study group | Role | What they receive |
|---|---|---|
| Interferon Alpha + Etoposide | Experimental | Interferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days Receives: Drug: Etoposide; Drug: Interferon Alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or > decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.
Measured: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startNov 1996
- Primary completionNov 2007
- Study completionMar 2009
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Eugenie S. Kleinerman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504140
- Sponsor's protocol ID
- P96-221
- Status last verified
- Aug 2012
- First submitted
- 17 Jul 2007
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
- ClinicalTrials.gov ID
- NCT00504140
- Acronym / sponsor ID
- P96-221
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Interferon Alpha, IFN-, Roferon, Recombinant Interferon Alpha, Etoposide, VP-16
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Nov 1996
- Primary completion
- Nov 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Jul 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.
Primary Objectives:
- To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
- To determine if IFN alters the plasma pharmacokinetics of etoposide.
- To determine the toxicities of IFN and etoposide when administered together.
- To determine IFN blood levels following combination therapy.
Detailed description
Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks (8 courses). The catheter will remain in place throughout treatment.
Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.
Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.
The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.
During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.
About 37 patients will be treated on the study at M. D. Anderson.
THIS IS AN INVESTIGATIONAL STUDY. IFN- and VP-16 are approved by the U.S. Food and Drug Administration for treating some types of cancer. Their use together against osteosarcoma is investigational.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon Alpha + Etoposide | Experimental | Drug: Etoposide, Drug: Interferon AlphaInterferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.
- Age 5-70 years.
- Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to 2.
- Patients must have measurable disease.
- Adequate hematologic, coagulation, renal, and hepatic function.
Key exclusion criteria (6 listed)
- Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
- Pregnant or lactating women.
- Patients who have had more than one prior biologic response modifier.
- Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
- Patients of childbearing potential, not practicing adequate contraception.
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 |
|---|---|---|
| EtoposideAlso: VP-16100 mg/m^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment. | Drug | Interferon Alpha + Etoposide |
| Interferon AlphaAlso: IFN-, Roferon5x10^6 mu/m^2 Subcutaneously Daily for 5 Days | Drug | Interferon Alpha + Etoposide |
Primary outcome
Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
Time frame: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)
Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or > decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.
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 2 Aug 2012.
- The University of Texas M.D.Anderson Cancer CenterLink 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.
Eugenie S. Kleinerman, MD principal investigator
M.D. Anderson Cancer 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 Etoposide and Interferon Alpha in people with Osteosarcoma, run by M.D. Anderson Cancer Center 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 6 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 2 Aug 2012. 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?
Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma. (time frame: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)). 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 2 Aug 2012.