BIO 300 Non-Small Cell Lung Cancer Study

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy and chemotherapy in patients with non-small cell lung cancer. Based on preclinical data the investigators hypothesize that BIO 300 Oral Suspension will reduce the incidence of radiation-induced pneumonitis and pulmonary fibrosis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanetics Corporation
• Collaborators: Henry Ford Health System; Medical College of Wisconsin; Milwaukee VA Medical Center; National Cancer Institute (NCI); University of Maryland, Baltimore
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Genistein; Paclitaxel

Criteria

Inclusion Criteria:

1. Histological or cytological confirmation of NSCLC

2. Stage II, III, or IV NSCLC for whom radiation therapy of 60 Gy and concurrent weekly paclitaxel/carboplatin is recommended

3. Up to three small (≤ 3 cm each) lung oligometastases will be allowed and/or one oligometastasis at any other site in the body

4. Eastern Cooperative Oncology Group Performance Scale (ECOG PS) of 0 or 1

5. Forced expiratory volume at one second (FEV1): best value obtained pre- or post-bronchodilator must be ≥ 1.0 liters/second or > 50% predicted value

6. Adequate bone marrow reserve

7. Adequate hepatic reserve

8. Adequate renal function

9. Female subjects of childbearing potential must have a negative pregnancy test

10. Female subjects of childbearing potential and male subjects with female sexual partners of childbearing potential must agree to use an effective method of contraception

11. Ability to read and provide written informed consent

Exclusion Criteria:

1. Weight loss greater than 10% in prior 4 weeks

2. Prior malignancy in which they received any thoracic radiotherapy unless the treating physician considers it unlikely to impact the clinical outcome of the patient

3. Patients with concurrent invasive malignancy other than non-melanoma skin cancer or cervical intraepithelial neoplasia unless the treating physician considers it unlikely to impact the clinical outcome of the patient

4. An active infection or with a fever ≥ 38.5°C

5. Poorly controlled intercurrent illnesses

6. Patients with a prior thoracotomy within 1 week of study registration

7. Chronic Obstructive Pulmonary Disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration

8. Patients with any of the following are not eligible:

• Previous history of Corrected QT Interval (QTc ) prolongation resulting from medication that required discontinuation of that medication

• Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age;

• Presence of left bundle branch block (LBBB);

• QTc with Fridericia's correction that is unmeasurable, or ≥ 480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be < 480 msec in order for the patient to be eligible for the study;

• Subjects taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes are not eligible if QTc ≥ 460 msec.

9. Patients must not have had a clinically significant cardiac event within 6 months before entry; or the presence of any other uncontrolled cardiovascular conditions that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.

10. Patients with a history of arrhythmia or asymptomatic sustained ventricular tachycardia are not eligible. Patients with atrial fibrillation with well-controlled ventricular rate on medication, are eligible.

11. Psychiatric conditions, social situations or substance abuse that precludes the ability of the subject to cooperate with the requirements of the trial and protocol therapy

12. Grade 2 or higher peripheral neuropathy

13. Known history of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), hepatitis B or C.

14. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

15. Women who are breastfeeding are not eligible for this study.