Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.

This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chemotherapy in Treating Patients With Solid Tumors

NCT00003698

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

NCT01112397

Solid Malignancies

TERMINATED PHASE1

AZD5438 in Patients With Advanced Solid Malignancies

NCT00088790

Neoplasms

COMPLETED PHASE1

Subjects With Advanced or Metastatic Solid Tumor Malignancies

NCT05474859

Metastatic Solid Tumor Advanced Solid Tumor

NOT_YET_RECRUITING PHASE1

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

NCT01226316

Advanced Solid Malignancy Safety and Tolerability Pharmacokinetics +11 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biomarker and health economics

Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.

Biomarker and health economics

Intervention Type PROCEDURE

Biomarkers CK18 and FLT3 Ligand will be collected

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biomarker and health economics

Biomarkers CK18 and FLT3 Ligand will be collected

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin \[Aapro et al, 2011a\].
* Age 18 or older
* Performance Status 0-2
* Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.

Exclusion Criteria

* Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
* Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
* Radio-immunotherapy within the last 8 weeks.
* Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) \[Gonzalez-Quintela et al, 2009, Lavallard et al, 2011\]
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No