NCT02331290

Brief Summary

This study is designed to determine if changes in acetyl amantadine (AA) metabolism with systemic chemotherapy - reflective of SSAT1 activity - are predictive of response to systemic therapy in patients with lung cancer. Ten patients with adenocarcinoma and 10 with small-cell cancer who are at American Joint Committee on Cancer (AJCC) stages 3 or 4 at the time of diagnosis will participate. AA metabolites will be examined by ELISA prior to initiation of systemic chemotherapy and after the second cycle of therapy. Changes in the pattern of metabolites will be correlated with convention clinical and radiographic response criteria.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

7.6 years

First QC Date

November 5, 2014

Last Update Submit

December 7, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Pattern of AA metabolite excretion/secretion relative to response to therapy.

    Correlation of AA metabolite excretion/secretion to response to systemic chemotherapy.

    Two months

Secondary Outcomes (1)

  • Pattern of AA metabolite excretion/secretion relative to time to recurrence or progression.

    Two years

Study Arms (1)

All patients

20 newly diagnosed patients with small-cell lung cancer and adenocarcinoma of the lung stage III or IV

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 patients: 10 patients with biopsy proven newly diagnosed Stage III or IV adenocarcinoma of the lung and 10 patients with Stage III or IV small-cell histology will be included.

You may qualify if:

  • Biopsy proven newly diagnosed advanced-stage small-cell lung cancer (SCLC) and adenocarcinoma of the lung being initiated on systemic chemotherapy.
  • Adequate hematological, renal and hepatic function sufficient to tolerate conventional doses of systemic chemotherapy.
  • Age \> 18 years.
  • Measurable or evaluable disease by Response Evaluation Criteria in solid Tumors (RECIST) criteria.
  • Performance score \< 3 (ECOG).
  • Capable of signing informed consent.

You may not qualify if:

  • Patients with significant liver and kidney disease, chronic drug therapy other then oral contraceptives. Pregnant or lactating female patients.
  • Women with childbearing potential must have a negative pregnancy test and be willing to use effective contraceptive techniques if sexually active.
  • Previous history of adverse reactions to amantadine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

NOT YET RECRUITING

Related Publications (1)

  • Bras AP, Janne J, Porter CW, Sitar DS. Spermidine/spermine n(1)-acetyltransferase catalyzes amantadine acetylation. Drug Metab Dispos. 2001 May;29(5):676-80.

    PMID: 11302933BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (2 x 10 ml) at 2 and 4 hours after amantadine ingestion. Saliva (2 x 5ml) immediately after the blood samples. Urine specimen between the time of the 2 blood samples. The sampling protocol will be repeated 3 weeks later with the second cycle of chemotherapy.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrew W Maksymiuk, MD FRCP(C)

    CancerCare Manitoba

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew W Maksymiuk, MD FRCP(C)

CONTACT

(204) 787-2021amaksymiuk@cancercare.mb.ca

Daniel S. Sitar, PhD

CONTACT

(204) 789-3532sitar@ms.umanitoba.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

January 6, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations

CA(2)