Trial · NCT01055314

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

NCT01055314, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma. Trials, record NCT01055314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01055314

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
NCT number: NCT01055314
Status: Completed
Phases: Phase 2
Enrollment: 175 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Untreated Childhood Rhabdomyosarcoma
Interventions: Cixutumumab, Cyclophosphamide, Dactinomycin, Doxorubicin Hydrochloride, Etoposide, Ifosfamide, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Temozolomide, Vincristine Sulfate Liposome
First posted: 2010-01-25
Last updated: 2017-08-29
Results first posted: 2017-07-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment	From start to week 26 of therapy	Proportion of no Grade 3+ cardiac toxicity.
Primary	Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment	From start to week 26 of therapy	Proportion of no Grade 4+ non-hematologic toxicity.
Primary	Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Up to 54 weeks	Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.
Primary	Event-Free Survival	3 years	Probability of no relapse, secondary malignancy, or death after 3 years in the study.
Secondary	Response Rate (CR + PR)	From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities	Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment	From start to week 26 of therapy	18 participants were excluded because of ineligibility or insufficient information to assess feasibility.	Proportion of Participants	NUMBER
PRIMARY	Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment	From start to week 26 of therapy	13 participants were excluded because of ineligibility or insufficient information to assess feasibility.	Proportion of Participants	NUMBER
PRIMARY	Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Up to 54 weeks	9 participants who were ineligible or did not receive treatment were excluded.	Participants	NUMBER
PRIMARY	Event-Free Survival	3 years	9 participants who were ineligible or did not receive treatment were excluded.	Probability	NUMBER
SECONDARY	Response Rate (CR + PR)	From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities	20 participants were excluded because of ineligibility or absence in overall response evaluation.	Proportion of Participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment	IMC-A12	0.9390	95% Confidence Interval 0.8872 to 0.9908	Proportion of Participants
Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment	Temozolomide	0.7097	95% Confidence Interval 0.5967 to 0.8227	Proportion of Participants
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0	IMC-A12	89		Participants
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Temozolomide	61		Participants
Event-Free Survival	IMC-A12	0.1627	95% Confidence Interval 0.0747 to 0.2507	Probability
Event-Free Survival	Temozolomide	0.1919	95% Confidence Interval 0.0407 to 0.3431	Probability
Response Rate (CR + PR)	IMC-A12	0.7667	95% Confidence Interval 0.6793 to 0.8540	Proportion of Participants
Response Rate (CR + PR)	Temozolomide	0.7846	95% Confidence Interval 0.6847 to 0.8846	Proportion of Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IMC-A12	100
Overall Study	STARTED	Temozolomide	75
Overall Study	COMPLETED	IMC-A12	55
Overall Study	COMPLETED	Temozolomide	37
Overall Study	NOT COMPLETED	IMC-A12	45
Overall Study	NOT COMPLETED	Temozolomide	38

Source ClinicalTrials.gov

Adverse events564

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal distension	Gastrointestinal disorders	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	2	96	2
other	Abdominal distension	Gastrointestinal disorders	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	1	70	1
other	Abdominal infection	Infections and infestations	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	1	96	1
other	Abdominal infection	Infections and infestations	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	1	70	1
other	Abdominal pain	Gastrointestinal disorders	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	7	96	8
other	Abdominal pain	Gastrointestinal disorders	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	8	70	10
other	Acidosis	Metabolism and nutrition disorders	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	1	96	3
other	Acidosis	Metabolism and nutrition disorders	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	2	70	3
other	Activated partial thromboplastin time prolonged	Investigations	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	0	96	0
other	Activated partial thromboplastin time prolonged	Investigations	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	1	70	1

1 to 10 of 564Source ClinicalTrials.gov

See all 564 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Total, all-cause mortality	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
Total, other adverse events	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	85	96
Total, other adverse events	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	63	70
Total, serious adverse events	Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)	79	96
Total, serious adverse events	Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)	40	70

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
IMC-A12 vs Temozolomide: Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0	Trial comparisons
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) vs Group 2 (Chemotherapy, Radiation Therapy, Temozolomide): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01055314

GET https://conductscience.org/api/trials/v1/NCT01055314/events?page=2

API reference For AI assistants