Ewing's SarcomaPhase 2NCT00038142
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
A Phase 2 study testing Vincristine, Doxorubicin and Cyclophosphamide in people with Ewing's Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy. 2. To evaluate the feasibility and describe the toxicity associated with VACdxr. 3. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Ewing's Sarcoma
- What is being tested?
- Vincristine, Doxorubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900 IU/ml prior to biopsy.
- No prior chemotherapy.
- Written informed consent
- Normal cardiac function (ejection fraction greater or equal to 50%).
- Males and non pregnant females.
- Biologic age 3-60 years old.
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- Adequate bone marrow function (defined as an absolute peripheral granulocyte count of>500/mm3, platelet count of >75,000/mm3, and hemoglobin >8g/dl with transfusion if required).
- Adequate renal function defined as blood urea nitrogen (BUN) <30mg% and serum creatinine <1.5 x normal for age or creatinine clearance >70.
- Patients of child bearing potential must agree to use an effective method of contraception.
- Normal hepatic function (bilirubin <1.5mg/dl, serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) <3x normal).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
Objectives:
- To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.
- To evaluate the feasibility and describe the toxicity associated with VACdxr.
- To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
- To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
Read the detailed description
Patients will be assigned at random (as by the toss of a coin) to receive 1 of 2 treatments.
Arm A: VACdxr will be given over 2 days through a needle in a vein. On day 1, vincristine will be given over 15 minutes, and doxorubicin will be given over 30 minutes.
Dexrazoxane will be given 30 minutes before doxorubicin; this drug protects the heart from damage by doxorubicin. Cyclophosphamide will be given once a day on days 1 and 2. This will make up 1 cycle of VACdxr treatment; the cycle will be repeated every 3 weeks for up to 6 cycles.
To prevent some side effects of VACdxr, the drugs Mesna and Neupogen/or Neulasta will also be given. Mesna helps prevent bladder damage. Neupogen is a growth factor that stimulates the body to make more white blood cells. Neulasta is a growth factor related to Neupogen.
After cycle 3, surgery may be done to remove any tumor that remains. The principal investigator will also decide whether radiation treatment should be done. If so, patients will receive radiation therapy.
Starting 1 month after all treatment is done, patients will receive ImmTher. ImmTher stimulates the body's white blood cells to attack and kill tumor cells. The drug will be given through a needle in a vein over 1 hour, every week for 1 year.
Arm B: Patients will be treated the same as patients in Arm A, except that they will not receive ImmTher.
Patients may have to stay in the hospital during VACdxr treatment and after surgery. Patients will receive ImmTher in the outpatient clinic.
Before treatment starts, patients will have a complete exam including blood and urine tests and an EKG and ECHO or multiple gated acquisition scan (MUGA) (heart function tests). X-rays and CT, MRI, bone marrow aspiration, and bone scans will be done. Women will have a pregnancy test.
After each treatment with drugs, after surgery, and after radiation treatment, patients will have checkups. These will include blood and urine tests and sometimes x-rays.
After cycle 3 of VACdxr, patients will have chest x-ray and x-ray of primary tumor. CT chest, MRI, bone marrow aspiration and bone scans will be done after 3 cycles as indicated. These tests will be done to record and measure tumors.
After treatment stops, patients will return for checkups every 3 months for 2 years.
This is an investigational study. ImmTher is an investigational agent. All other study drugs are approved by the U.S. Food and Drug Administration. As many as 104 patients will take part in the study; about 95 of these will be treated at M.D. Anderson.
- Conditions
- Ewing's Sarcoma
- Being tested
- Vincristine, Doxorubicin, Cyclophosphamide, Dexrazoxane, ImmTher
- Keywords
- Ewing's Sarcoma, Vincristine, Doxorubicin, Adriamycin, Rubex, Cyclophosphamide, Dexrazoxane, Zinecard, VACdxr, ImmTher
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
DoxorubicinDrug
Also called Adriamycin, Rubex
90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6.
CyclophosphamideDrug
Also called Cytoxan, Neosar
2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6.
DexrazoxaneDrug
Also called DXR, Zinecard
900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
ImmTherBiological
900 mcg/m^2 IV over 1 hour every week x 50-52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: VACdxr With ImmTher | Experimental | Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks. Receives: Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Dexrazoxane; Biological: ImmTher |
| Arm B: VACdxr | Active comparator | Chemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). Receives: Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Dexrazoxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer
DFS defined as survival of participants to two years post study entry without relapse.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startNov 1997
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ewing's SarcomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenie S. Kleinerman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038142
- Sponsor's protocol ID
- ID97-198
- Other IDs
- NCI-2012-01285
- Status last verified
- Jan 2020
- First submitted
- 29 May 2002
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
- ClinicalTrials.gov ID
- NCT00038142
- Acronym / sponsor ID
- ID97-198
- Conditions
- Ewing's Sarcoma
- Keywords
- Ewing's Sarcoma, Vincristine, Doxorubicin, Adriamycin, Rubex, Cyclophosphamide, Dexrazoxane, Zinecard
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 1997
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 May 2002 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To determine if dose intensive Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without ImmTherTM can improve the 2-year disease-free survival seen with standard VAC therapy.
- To evaluate the feasibility and describe the toxicity associated with VACdxr.
- To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks.
- To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
Detailed description
Patients will be assigned at random (as by the toss of a coin) to receive 1 of 2 treatments.
Arm A: VACdxr will be given over 2 days through a needle in a vein. On day 1, vincristine will be given over 15 minutes, and doxorubicin will be given over 30 minutes.
Dexrazoxane will be given 30 minutes before doxorubicin; this drug protects the heart from damage by doxorubicin. Cyclophosphamide will be given once a day on days 1 and 2. This will make up 1 cycle of VACdxr treatment; the cycle will be repeated every 3 weeks for up to 6 cycles.
To prevent some side effects of VACdxr, the drugs Mesna and Neupogen/or Neulasta will also be given. Mesna helps prevent bladder damage. Neupogen is a growth factor that stimulates the body to make more white blood cells. Neulasta is a growth factor related to Neupogen.
After cycle 3, surgery may be done to remove any tumor that remains. The principal investigator will also decide whether radiation treatment should be done. If so, patients will receive radiation therapy.
Starting 1 month after all treatment is done, patients will receive ImmTher. ImmTher stimulates the body's white blood cells to attack and kill tumor cells. The drug will be given through a needle in a vein over 1 hour, every week for 1 year.
Arm B: Patients will be treated the same as patients in Arm A, except that they will not receive ImmTher.
Patients may have to stay in the hospital during VACdxr treatment and after surgery. Patients will receive ImmTher in the outpatient clinic.
Before treatment starts, patients will have a complete exam including blood and urine tests and an EKG and ECHO or multiple gated acquisition scan (MUGA) (heart function tests). X-rays and CT, MRI, bone marrow aspiration, and bone scans will be done. Women will have a pregnancy test.
After each treatment with drugs, after surgery, and after radiation treatment, patients will have checkups. These will include blood and urine tests and sometimes x-rays.
After cycle 3 of VACdxr, patients will have chest x-ray and x-ray of primary tumor. CT chest, MRI, bone marrow aspiration and bone scans will be done after 3 cycles as indicated. These tests will be done to record and measure tumors.
After treatment stops, patients will return for checkups every 3 months for 2 years.
This is an investigational study. ImmTher is an investigational agent. All other study drugs are approved by the U.S. Food and Drug Administration. As many as 104 patients will take part in the study; about 95 of these will be treated at M.D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: VACdxr With ImmTher | Experimental | Drug: Vincristine, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Dexrazoxane, Biological: ImmTherChemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) intravenous (IV), Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days. Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). ImmTher 900 mcg/m^2 IV over 1 hour every week x 50-52 weeks. |
| Arm B: VACdxr | Active comparator | Drug: Vincristine, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: DexrazoxaneChemotherapy repeated every 3 weeks for 6 cycles: Vincristine 2.0 mg/m^2 (max 2.0 mg) IV. Doxorubicin 90 mg/m^2 IV over 30 minutes, Cyclophosphamide 2.0 g/m^2 IV daily for 2 days, Dexrazoxane 900 mg/m^2 IV (30 minutes prior to doxorubicin). |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900 IU/ml prior to biopsy.
- No prior chemotherapy.
- Written informed consent
- Normal cardiac function (ejection fraction greater or equal to 50%).
- Males and non pregnant females.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vincristine2.0 mg/m^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6. | Drug | Arm A: VACdxr With ImmTher, Arm B: VACdxr |
| DoxorubicinAlso: Adriamycin, Rubex90 mg/m^2 IV over 30 min x 1 repeated every 3 weeks X 6. | Drug | Arm A: VACdxr With ImmTher, Arm B: VACdxr |
| CyclophosphamideAlso: Cytoxan, Neosar2.0 g/m^2 IV daily x 2 days repeated every 3 weeks X 6. | Drug | Arm A: VACdxr With ImmTher, Arm B: VACdxr |
| DexrazoxaneAlso: DXR, Zinecard900 mg/m^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6. | Drug | Arm A: VACdxr With ImmTher, Arm B: VACdxr |
| ImmTher900 mcg/m^2 IV over 1 hour every week x 50-52 weeks. | Biological | Arm A: VACdxr With ImmTher |
Primary outcome
2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer
Time frame: 2 years
DFS defined as survival of participants to two years post study entry without relapse.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center 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.
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 Vincristine, Doxorubicin and Cyclophosphamide in people with Ewing's Sarcoma, 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 10 inclusion and 0 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: stopped early, as of the sponsor's last update on 29 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
2-year Disease-free Survival (DFS): Effect of Treatment With Combination Drugs in VACdxr Given in High Doses With or Without ImmTher to Help Participants With Ewing's Sarcoma Live Longer (time frame: 2 years). 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 29 Jan 2020.