Recruiting

Acetylamantadine

Sponsor:

University of Manitoba

Code:

NCT02331290

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT02331290

Start date

May, 2016

Status verified date

Dec, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

All patients

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

Primary outcome measure

  • Pattern of AA metabolite excretion/secretion relative to response to therapy. [ Time Frame: Two months ]

Central Contacts and Locations

Central contacts

Andrew W Maksymiuk, MD FRCP(C)

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

Daniel S. Sitar, PhD

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

Locations

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

Paramjit S Tappia, PhD

204-258-1230ptappia@sbrc.ca

Andrew Maksymiuk, MD

204-7871884amaksymiuk@cancercare.mb.ca

More Information

Sponsor

University of Manitoba

Last update posted

Dec 8, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2022-12-08.