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Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers

This study has been terminated.
(low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382745
First Posted: June 27, 2011
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
YM BioSciences
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital
  Purpose
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.

Condition Intervention Phase
Squamous Cell Carcinoma of Anal Canal Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy (IMRT) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal

Further study details as provided by Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 1 month post end of treatment ]
    Toxicity evaluation will include all toxicities occurring while the patient is receiving treatment, and will be monitored using the CTCAE guide version 3.0.

  • Local tumor response rate [ Time Frame: 8 weeks post end of radiation treatment ]
    Tumor response rates will be evaluated using the MRI performed at 8-weeks post end of radiotherapy treatment.


Secondary Outcome Measures:
  • Overall cancer-free survival [ Time Frame: 5 years post end of treatment ]
  • Overall survival [ Time Frame: 5 years post end of treatment ]

Enrollment: 1
Study Start Date: January 2012
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nimotuzumab
Patients will receive weekly injections of Nimotuzumab (200mg/injection) for 12 weeks and standard external beam radiotherapy
Drug: Nimotuzumab
200mg Nimotuzumab once a week for 12 weeks
Radiation: Intensity Modulated Radiation Therapy (IMRT)
IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382745


Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Dr. Te Vuong
YM BioSciences
Investigators
Principal Investigator: Te Vuong, MD Jewish General Hospital
  More Information

Responsible Party: Dr. Te Vuong, MD-Director Radiation Oncology, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01382745     History of Changes
Other Study ID Numbers: 11-044
First Submitted: June 24, 2011
First Posted: June 27, 2011
Last Update Posted: January 28, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell