Clinical trial · Interventional
Vincristine, Dactinomycin, and Cyclophosphamide in Treating Patients With Embryonal Rhabdomyosarcoma
Phase II Trial of VAC2.2/VA Therapy for Low-Risk B Group Patients With Rhabdomyosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together works in treating patients with embryonal rhabdomyosarcoma.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival at 3 years after study registration
Secondary outcomes (2)
- measure
- Overall survival at 3 years after study registration
- measure
- Toxicity by NCI CTC at 3 years after study registration
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of embryonal rhabdomyosarcoma
* Primary operation for pathological diagnosis within the past 42 days
* The following variants are eligible:
* Botryoid
* Spindle cell
* Anaplastic
* Meets 1 of the following stage criteria:
* Stage I, clinical group II (N1)
* Favorable site
* Any tumor size
* Microscopic residual disease
* Lymph nodes clinically positive
* Stage I, clinical group III (N1)
* Favorable site (orbit only)
* Any tumor size
* Gross residual disease
* Lymph nodes clinically positive
* Stage I, clinical group III (N0, NX, N1)
* Favorable site (except orbit)
* Any tumor size
* Gross residual disease
* Lymph nodes clinically negative, involvement unknown, or positive
* Stage II, clinical group II (N0, NX)
* Unfavorable site
* Small tumor (≤ 5 cm in diameter)
* Microscopic residual disease
* Stage III, clinical group I or II (N0, NX, N1)
* Unfavorable site
* Small tumor (≤ 5 cm in diameter) with positive nodes or large tumor (\> 5 cm in diameter) with any lymph nodes status
* Completely resected or microscopic residual disease
PATIENT CHARACTERISTICS:
Performance status
* 0-3
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 7.5 g/dL
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
* Bile acid ≤ 2.5 times ULN
Renal
* Creatinine based on age as follows:
* ≤ 0.8 mg/dL (for patients \< 5 years of age)
* ≤ 1.2 mg/dL (for patients 5-9 years of age)
* ≤ 1.5 mg/dL (for patients ≥ 10 years of age)
Cardiovascular
* No severe heart disease
Other
* Not pregnant or nursing
* No uncontrolled infection
* Must have acceptable organ function for age
* No other malignancy within the past 5 years
* No hypersensitivity attributed to study drugs
* No Charcot-Marie-Tooth disease or chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior anticancer chemotherapy
Endocrine therapy
* Prior anticancer steroids allowed
Radiotherapy
* Prior emergency radiotherapy allowed within the past 2 weeks
Other
* No concurrent pentostatinReferences
Publications (0)
Data not yet available