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

Cancer Clinical Trial

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01476085
• Other study ID #: 114238
• Status: Terminated
• Phase: Phase 1
• First received: September 1, 2011
• Last updated: June 27, 2013
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer
• Lymphoma, Non-Hodgkin

Intervention

Radiation:
• ML10
[18F]ML10 radioligand apoptosis biomarker

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in [18F]ML10 uptake in tumours	Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.	between baseline at day 0 and between 14-20 days after	No
Secondary	alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes	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.	between baseline at day 0 and between 14-20 days after	No
Secondary	voxel-based uptake map of [18F]ML10 in the target lesion	Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.	between baseline at day 0 and between 14-20 days after	No