Clinical trial · Interventional
Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma
Phase II Trial of Neoadjuvant Dose-Dense Doxorubicin, Ifosfamide, and Irinotecan (CPT-11) for Advanced Soft Tissue and Recurrent Bone Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prematurely due to withdrawal of support by the sponsor.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Giving combination chemotherapy together with dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with dexrazoxane followed by surgery and radiation therapy works in treating patients with advanced soft tissue sarcoma or recurrent bone sarcoma.
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 |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| dexrazoxane hydrochloride | Drug | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| immunoenzyme technique | Other | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
- interventionNames
- Biological: filgrastim
- Drug: dexrazoxane hydrochloride
- Drug: doxorubicin hydrochloride
- Drug: ifosfamide
- Drug: irinotecan hydrochloride
- Genetic: protein expression analysis
- Other: immunoenzyme technique
- Procedure: adjuvant therapy
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.
- description
- Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Primary soft tissue sarcoma at high-risk\* for recurrence, meeting any of the following criteria:
* Previously untreated locally advanced, nonmetastatic disease
* Advanced (metastatic) disease not amenable to standard or higher priority investigational neoadjuvant therapies
* Recurrent bone sarcoma (e.g., osteogenic sarcoma, Ewing sarcoma, or peripheral neuroectodermal tumor)
* Must have advanced locally recurrent or metastatic disease NOTE: \*High-risk is defined as high-grade, deep to fascia, and \> 5 cm in greatest dimension
* Measurable or nonmeasurable disease is not required
* Pre-chemotherapy consultation with surgery and radiation oncology is required for formulation of loco-regional therapy
* No gastrointestinal stromal cell sarcoma
* No alveolar soft part sarcoma
* No symptomatic brain metastases
* No requirement for anticonvulsant or corticosteroid therapy
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy ≥ 2 months
* Absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count \> 120,000/mm\^3
* Creatinine clearance \> 50 mL/min
* Serum bilirubin ≤ 1.5 mg/dL
* SGOT or SGPT ≤ 2.5 times upper limit of normal
* Serum albumin ≥ 2.5 mg/dL
* LVEF ≥ 50% by MUGA scan
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent nonmalignant illness (e.g., cardiovascular, pulmonary, or CNS disease) that is poorly controlled with currently available treatment or is of such severity that the investigators deem it unwise for the patient to enter the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy for recurrent (local or metastatic) soft tissue sarcoma
* Prior chemotherapy for recurrent bone sarcoma allowed provided the total dose of doxorubicin hydrochloride is ≤ 300 mg/m\^2
* No prior radiotherapy to \> 25% of bone marrow
* At least 3 weeks since prior radiotherapy or chemotherapyReferences
Publications (0)
Data not yet available