Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)

This study has been terminated.
(Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476085
First received: September 1, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.


Condition Intervention Phase
Cancer
Radiation: ML10
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • changes in [18F]ML10 uptake in tumours [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
    Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.


Secondary Outcome Measures:
  • alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
    Relationship between alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes in response to chemotherapy as measured by standard of care CT scan and FDG PET scan.

  • voxel-based uptake map of [18F]ML10 in the target lesion [ Time Frame: between baseline at day 0 and between 14-20 days after ] [ Designated as safety issue: No ]
    Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.


Enrollment: 1
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no treatment
no treatment
Radiation: ML10
[18F]ML10 radioligand apoptosis biomarker

Detailed Description:

Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. In addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
  2. Male or female patients >18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
  3. A female subject is eligible to participate if she has non-childbearing potential
  4. Male subject must agree to use one of the contraception methods listed
  5. Able to lie comfortably on back for up to 70 minutes at a time.
  6. WHO performance status 0, 1 or 2 -

Exclusion Criteria:

  1. Patients with known history of Hepatitis B, C, non-A, non-B and HIV
  2. Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
  3. Pregnant or breast feeding females.
  4. Any other prior anticancer therapy
  5. Any new investigational agent, including an investigational anti-cancer agent
  6. History of sensitivity to heparin or heparin-induced thrombocytopenia.
  7. Males and females not able to comply with contraceptive guidelines during the study.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476085

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, W12 0NN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476085     History of Changes
Other Study ID Numbers: 114238
Study First Received: September 1, 2011
Last Updated: June 27, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014