Clinical trial · Observational
Excretion of Acetylamantadine (AA) by Lung Cancer Patients During a Chemotherapy Regimen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- 20 newly diagnosed patients with small-cell lung cancer and adenocarcinoma of the lung stage III or IV
Primary outcomes (1)
- measure
- Pattern of AA metabolite excretion/secretion relative to response to therapy.
- timeFrame
- Two months
- description
- Correlation of AA metabolite excretion/secretion to response to systemic chemotherapy.
Secondary outcomes (1)
- measure
- Pattern of AA metabolite excretion/secretion relative to time to recurrence or progression.
- timeFrame
- Two years
- description
- Correlation of AA metabolite excretion/secretion to time to disease recurrence or progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBras 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 11302933