Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00831844




Registration number
NCT00831844
Ethics application status
Date submitted
28/01/2009
Date registered
29/01/2009
Date last updated
30/03/2015

Titles & IDs
Public title
Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
Scientific title
A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, NSC #742460) in Children With Relapsed/Refractory Solid Tumors
Secondary ID [1] 0 0
NCI-2009-01170
Secondary ID [2] 0 0
NCI-2009-01170
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Rhabdomyosarcoma 0 0
Adult Synovial Sarcoma 0 0
Childhood Hepatoblastoma 0 0
Childhood Synovial Sarcoma 0 0
Previously Treated Childhood Rhabdomyosarcoma 0 0
Recurrent Adrenocortical Carcinoma 0 0
Recurrent Adult Soft Tissue Sarcoma 0 0
Recurrent Childhood Liver Cancer 0 0
Recurrent Childhood Rhabdomyosarcoma 0 0
Recurrent Childhood Soft Tissue Sarcoma 0 0
Recurrent Ewing Sarcoma/Peripheral Primitive 0 0
Neuroectodermal Tumor 0 0
Recurrent Neuroblastoma 0 0
Recurrent Osteosarcoma 0 0
Recurrent Retinoblastoma 0 0
Recurrent Wilms Tumor and Other Childhood Kidney Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Eye 0 0 0 0
Diseases / disorders of the eye
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Liver
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - cixutumumab
Other interventions - laboratory biomarker analysis

Experimental: Group 1 - Recurrent or Refractory Hepatoblastoma - Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Group 2 - Recurrent or Refractory Synovial Sarcoma - Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Group 3 - Recurrent or Refractory Rhabdomyosarcoma - Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Grp 4-Recurrent or Refractory Adrenocortical Carcinoma - Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor - Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease - Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Grp 7-Neuroblastoma with measurable disease - Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Group 8 - Recurrent Osteosarcoma - Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Group 9 - Recurrent or Refractory Wilms Tumor - Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Experimental: Group 10 - Recurrent or Refractory Retinoblastoma - Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.


Treatment: Other: cixutumumab
Given IV: Week 1 day 1, 9 mg/kg/dose over 1 hour. Week 2 Day 8, 9 mg/kg/dose over 1 hour. Week 3 Day 15, 9 mg/kg/dose over 1 hour. Week 4 Day 22, 9 mg/kg/dose over 1 hour.

Other interventions: laboratory biomarker analysis
Correlative studies
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Response
Timepoint [1] 0 0
First six treatment cycles - 24 weeks

Eligibility
Key inclusion criteria
* Histologically confirmed malignant solid tumor, including the following:

* Osteosarcoma
* Ewing sarcoma/peripheral primitive neuroectodermal tumor
* Rhabdomyosarcoma
* Neuroblastoma
* Wilms tumor
* Synovial sarcoma
* Hepatoblastoma
* Adrenocortical carcinoma
* Retinoblastoma
* No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
* Radiographically measurable disease*, defined as = 1 unidimensionally measurable lesion = 20 mm by MRI or CT scan or = 10 mm by spiral CT scan

* The following are not considered measurable disease:

* Ascites, pleural effusions, or other malignant fluid collections
* Bone marrow infiltration by tumor
* Lesions detected only by non-MIBG nuclear medicine studies (e.g., bone scan)
* Previously irradiated lesions that have not demonstrated clear progression post-radiotherapy
* No known Central Nervous System (CNS) metastases unless they were treated by surgery or radiotherapy AND are stable with no recurrent lesions for = 3 months
* Lansky or Karnofsky performance status (PS) 50-100% OR Eastern Cooperative Oncology Group (ECOG) PS 0-2
* Absolute neutrophil count (ANC) = 1,000/mm³ (> 250/mm³ for patients with neuroblastoma)
* Platelet count = 75,000/mm³ (> 25,000/mm³ for patients with neuroblastoma) (transfusion independent)
* Hemoglobin = 8.0 g/dL (= 7.5 g/dL for patients with neuroblastoma) (RBC transfusion allowed)
* Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR serum creatinine normal based on age/gender as follows:

* = 0.4 mg/dL (for patients 1 to 5 months of age)
* = 0.5 mg/dL (for patients 6 to 11 months of age)
* = 0.6 mg/dL (for patients 1 year of age)
* = 0.8 mg/dL (for patients 2 to 5 years of age)
* = 1 mg/dL (for patients 6 to 9 years of age)
* = 1.2 mg/dL (for patients 10 to 12 years of age)
* = 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
* = 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients = 16 years of age)
* Total bilirubin = 1.5 times upper limit of normal for age
* Alanine transaminase (ALT) = 110 U/L
* Serum albumin = 2 g/dL
* Blood glucose normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Able to comply with safety monitoring requirements of study
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drug
* No uncontrolled infection
* No known type I or II diabetes mellitus
* Recovered from prior chemotherapy, immunotherapy, or radiotherapy
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
* At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim)
* At least 6 weeks since prior monoclonal antibody therapy
* At least 7 days since other prior antineoplastic biologic agents
* No prior monoclonal antibody targeting the IGF-IR
* No prior small molecule kinase inhibitors of IGF-IR
* At least 2 weeks since prior local palliative (small port) radiotherapy
* At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to = 50% of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* At least 2 months since prior stem cell transplantation

* No evidence of graft-versus-host disease
* Concurrent corticosteroids allowed provided dose is stable or decreasing over the past 7 days

* Intermittent use of corticosteroids to manage infusional reactions allowed
* No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
* No other concurrent investigational agents
* No concurrent insulin or growth hormone therapy
Minimum age
7 Months
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [4] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Newfoundland and Labrador
Country [40] 0 0
Canada
State/province [40] 0 0
Nova Scotia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brenda Weigel, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00831844