# Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma

> **NCT01055314** · PHASE2 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 175 (actual)

## Conditions studied

- Adult Rhabdomyosarcoma
- Childhood Alveolar Rhabdomyosarcoma
- Childhood Embryonal Rhabdomyosarcoma
- Metastatic Childhood Soft Tissue Sarcoma
- Stage IV Adult Soft Tissue Sarcoma
- Untreated Childhood Rhabdomyosarcoma

## Interventions

- **BIOLOGICAL:** Cixutumumab
- **DRUG:** Cyclophosphamide
- **BIOLOGICAL:** Dactinomycin
- **DRUG:** Doxorubicin Hydrochloride
- **DRUG:** Etoposide
- **DRUG:** Ifosfamide
- **DRUG:** Irinotecan Hydrochloride
- **OTHER:** Laboratory Biomarker Analysis
- **DRUG:** Temozolomide
- **DRUG:** Vincristine Sulfate Liposome

## Key facts

- **NCT ID:** NCT01055314
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-01
- **Primary completion:** 2016-06
- **Final completion:** 2016-06
- **Target enrollment:** 175 (ACTUAL)
- **Last updated:** 2017-08-29


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01055314

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01055314, "Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma". Retrieved via AI Analytics 2026-07-07 from https://api.ai-analytics.org/clinical/NCT01055314. Licensed CC0.

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