A Phase 2 interventional study of Vincristine and Doxorubicin in Ewing's Sarcoma, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 3 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
Objectives:
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.
290 studies on the registry are indexed under Sarcoma, Ewing; 67 are open to participants now.
This study's enrollment of 46 is above the median of 39 across 228 interventional studies indexed under Sarcoma, Ewing.
Browse Sarcoma, Ewing studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: N/A
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.
Drug: Vincristine · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Dexrazoxane · Biological: ImmTher
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).
Drug: Vincristine · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Dexrazoxane
2.0 mg/m\^2 (max 2.0 mg) IV x 1 repeated every 3 weeks X 6.
90 mg/m\^2 IV over 30 min x 1 repeated every 3 weeks X 6.
Also known as: Adriamycin, Rubex
2.0 g/m\^2 IV daily x 2 days repeated every 3 weeks X 6.
Also known as: Cytoxan, Neosar
900 mg/m\^2 IV (30 min prior to doxorubicin) repeated every 3 weeks X 6.
Also known as: DXR, Zinecard
900 mcg/m\^2 IV over 1 hour every week x 50-52 weeks.
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.
Time frame: 2 years
Recruitment Period: November 13, 1997 to December 7, 2009. Recruitment was done within medical clinic settings.
| Milestone | Arm A: VACdxr With ImmTher | Arm B: VACdxr |
|---|---|---|
| Started | 32 | 14 |
| Completed | 10 | 7 |
| Not completed | 22 | 7 |
| Withdrew: Ineligible | 1 | 0 |
| Withdrew: Progressive disease | 11 | 7 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Unknown reason | 8 | 0 |
DFS defined as survival of participants to two years post study entry without relapse.
No measurements were reported for this outcome.
Collected over Adverse event (AE) data collected for up to 6 three-week cycles of chemotherapy then up to 30 days post drug treatment which may be received for one year if receiving ImmTher.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: VACdxr With ImmTher | — | 1/31 (3.2%) | 31/31 (100%) |
| Arm B: VACdxr | — | 0/14 (0%) | 14/14 (100%) |
| Event | Arm A: VACdxr With ImmTher | Arm B: VACdxr |
|---|---|---|
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 1/31 | 0/14 |
| Event | Arm A: VACdxr With ImmTher | Arm B: VACdxr |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 23/31 | 10/14 |
| ThrombocytopeniaVascular disorders | 23/31 | 10/14 |
| GranulocytopeniaBlood and lymphatic system disorders | 20/31 | 10/14 |
| LeukopeniaBlood and lymphatic system disorders | 22/31 | 10/14 |
| VomitingGastrointestinal disorders | 21/31 | 10/14 |
| Nausea AloneGastrointestinal disorders | 22/31 | 9/14 |
| HeadacheNervous system disorders | 19/31 | 3/14 |
| Rigors, ChillsGeneral disorders | 19/31 | 0/14 |
| Fever NeutropenicInvestigations | 17/31 | 8/14 |
| StomatitisGastrointestinal disorders | 14/31 | 2/14 |
| Age, Continuous(years) | Arm A: VACdxr With ImmTher | Arm B: VACdxr | Total |
|---|---|---|---|
| Median | 15 (4 to 50) | 17 (6 to 37) | 16 (4 to 50) |
| Sex: Female, Male(Participants) | Arm A: VACdxr With ImmTher | Arm B: VACdxr | Total |
|---|---|---|---|
| Female | 13 | 6 | 19 |
| Male | 19 | 8 | 27 |
| Region of Enrollment(participants) | Arm A: VACdxr With ImmTher | Arm B: VACdxr | Total |
|---|---|---|---|
| United States | 32 | 14 | 46 |
The record gives a start of Nov 1997, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2020, 3 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.