Clinical trial · Interventional
Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) in High Risk Ewing's Sarcoma Patients
Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) With or Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
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. To evaluate the feasibility and describe the toxicity of administering ImmTherTM on a weekly basis for 50- 52 weeks. 4. To determine which therapy (VACdxr+ or VACdxr-) is worthy of further evaluation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexrazoxane | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| ImmTher | Biological | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: VACdxr With ImmTher
- description
- 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.
- interventionNames
- Drug: Vincristine
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Dexrazoxane
- Biological: ImmTher
- type
- ACTIVE_COMPARATOR
- label
- Arm B: VACdxr
- description
- 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).
- interventionNames
- Drug: Vincristine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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). Exclusion Criteria: N/A
References
Publications (0)
Data not yet available