Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02535325 : Methoxyamine, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have pathologic diagnosis of adenocarcinoma or large cell carcinoma of
the lung with confirmation by immunohistochemistry (e.g., transcription termination
factor 1 [TTF-1] positivity) (histologic tissue diagnosis is recommended, but
cytology is acceptable); stage IIIA/IIIB or oligometastatic stage IV in which the
patient is still considered an appropriate candidate for aggressive chemoradiotherapy
for the primary tumor; oligometastatic disease is defined as =< 5 metastatic sites
(=< 3 lesions per organ); for intracranial metastasis, the patient should have
asymptomatic disease that is stable on steroids or 1 to 3 symptomatic metastatic
lesions treated with stereotactic radiosurgery (SRS)

- Eastern Cooperative Oncology Group (ECOG) performance status < 2

- Life expectancy of greater than 12 months

- Ability to swallow and retain orally-administered medication and does not have any
clinically significant gastro-intestinal abnormalities (e.g., malabsorption syndrome
or major resection of the stomach or bowel)

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
2.5 × institutional upper limit of normal

- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5
× institutional upper limit of normal

- Creatinine within normal institutional limits OR

- Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
institutional normal

- Hemoglobin >= 9 g/dL without transfusion within 7 days prior to enrollment

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately; men and women treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of study participation, and 4 months after completion of methoxyamine
administration

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients who have had prior chemotherapy or any other investigational drug within 30
days of registration or prior radiotherapy to the study treatment volume; prior
surgery is allowed; there must be at least 6 weeks between mitomycin or nitrosoureas
and any new therapy

- Patients who are receiving any other investigational agents

- Patients with a history of any active malignancy requiring on-going treatment, except
basal cell carcinoma or squamous cell carcinoma of the skin

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to methoxyamine or to pemetrexed or cisplatin

- Undetectable haptoglobin or evidence of glucose-6-phophate dehydrogenase (G6PD)
deficiency, pyruvate kinase deficiency, hemoglobinopathy, hereditary spherocytosis,
thalassemia or other disorder associated with hemolysis

- Patients receiving any medications or substances that are inhibitors or inducers of
nonsteroidal anti-inflammatory drugs (NSAIDS), probenecid, salisylates, sulfonamides
are ineligible; concomitant drugs that are sensitive cytochrome P450 (CYP450)
substrates or strong and moderate CYP450 inducers and inhibitors should be avoided;
as part of the enrollment/informed consent procedures, the patient will be counseled
on the risk of interactions with other agents, and what to do if new medications need
to be prescribed or if the patient is considering a new over-the-counter medicine or
herbal product

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with methoxyamine

- Patients who are known to be human immunodeficiency positive (HIV)-positive and are
on combination antiretroviral therapy are ineligible
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02535325      |      Link to official Clinicaltrials.gov listing
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