Nimotuzumab With Radiotherapy in the Treatment of Anal Ca... | NCT01382745

Studies
Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

NCT01382745

Sponsor

Dr. Te Vuong

Status

Terminated

Last Update Posted

Jan 28, 2013Estimated

Enrollment

1Actual

Phase

Phase 2

Conditions

Squamous Cell Carcinoma of Anal Canal

Interventions

Nimotuzumab
Intensity Modulated Radiation Therapy (IMRT)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low recruitment

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jun 24, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2013

Last Update Posted Date

Jan 28, 2013Estimated

Name	Class
YM BioSciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to demonstrate the feasibility of using Nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. Patients with high toxicity risks (HIV+ and fragile patients) will be selected for this study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nimotuzumab	Experimental	Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy	Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nimotuzumab	Drug	200mg Nimotuzumab once a week for 12 weeks	Nimotuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Toxicity	Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.	1 month post end of treatment
Local tumor response rate	Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.	8 weeks post end of radiation treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall cancer-free survival		5 years post end of treatment
Overall survival		5 years post end of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For both step I and II:

Patients with histologically confirmed squamous cell carcinoma of the anal canal
Aged 18 years or older
ECOG: 0-1-2
Adequate contraception in women of child-bearing potential and for men
Ability to understand and the willingness to sign a written informed consent document.
HIV-positive patients with T1-2 anal canal tumors, or
Patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
Patients who have already started radiotherapy for anal canal cancer

For step II:

HIV-positive patients with T1, T2 anal canal tumors
HIV-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities)
HIV-negative patients with T1-2 anal canal cancer

Exclusion Criteria:

For both step I and II:

Patients receiving any other investigational agents
Previous treatment with anti-EGFR drugs
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nimotuzumab or other agents used in study.
Previously treated with pelvic radiotherapy.
Lesions not suitable for radiotherapy
Patients with uncontrolled hypercalcemia
Uncontrolled intercurrent illness
Pregnant or breast-feeding women
Any concurrent active malignancy
Patients with T3-4 anal canal tumors or patients with nodes positive.

Step I:

HIV-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-FU and MMC chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C501466	nimotuzumab
D050397	Radiotherapy, Intensity-Modulated

ID	Term
D020266	Radiotherapy, Conformal
D011881	Radiotherapy, Computer-Assisted
D011878	Radiotherapy
D013812	Therapeutics