Safety, Feasibility, and Dose Study of Aethlon Hemopurifier in Solid Tumor Patients on Pembrolizumab or Nivolumab Monotherapy.

Not Applicable

• Conditions: Cancer; Cancer - Lung - Non small cell; Cancer - Malignant melanoma; Cancer - Bladder; Cancer - Kidney; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Head and neck; Cancer - Stomach; Cancer - Cervical (cervix); Cancer - Lung - Mesothelioma

• Registration Number: ACTRN12624000732583
• Lead Sponsor: Aethlon Medical Australia PTY Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Histologic diagnosis of one of the following solid tumors:
Non-small cell lung cancer
Melanoma
Bladder/urinary tract cancer (urothelial cancer)
Renal cancer
Colorectal cancer (microsatellite instability-high (msi-h)
or a mismatch repair deficient (dmmr) solid tumor)
Gastric or gastroesophageal junction or esophageal cancer
Head and neck cancer
Cervical cancer
Mesothelioma

2. Patient is going to receive treatment with pembrolizumab or nivolumab
monotherapy or has been receiving this treatment for less than or equal to 2 weeks.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1
Measurable disease by RECIST 1.1.
5. greater than or equal to 18 years of age.
6. Ability to provide informed consent.
7. Life expectancy of at least 12 weeks.
8. Women of childbearing potential (WOCBP) and men must agree to use
adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and through 120 days after the HP
treatment. Should a woman become pregnant or suspect she is pregnant
while she or her partner is participating in this study, the treating physician
should be informed immediately. Men treated or enrolled on this protocol
must also agree to use adequate contraception prior to the study and for the
duration of study participation.

Exclusion Criteria

1. Presence of brain or leptomeningeal metastasis.
2. Immunodeficiency disorder.
3. Use of more than 10 mg/day of prednisone or equivalent in the 30 days
leading up to enrollment.
4. Any autoimmune condition requiring treatment in the year prior to
enrollment.
5. Currently being treated for acute non-infectious pneumonitis.
6. Pregnant or breastfeeding (WOCBP must have a negative urine pregnancy
test on the day but prior to the first HP treatment).
7. HIV infection.
8. Active hepatitis B or C infection.
9. Use of an angiotensin-converting enzyme (ACE) inhibitor within 14 days
prior to a HP treatment.
10. Systolic blood pressure <100 mmHg during Screening Period in a patient
with a history of a systolic blood pressure greater than or equal to 100 mmHg.
11. Contraindication to anticoagulation:
-->Unable to tolerate full therapeutic anticoagulation therapy for any reason
12. Hemoglobin < 9g/dl
13. Absolute Neutrophil count < 1500 cells/mm3
14. Platelet count <75,000 cells/mm3.
15. Creatinine Clearance < 45 ml/min (2021 CKD-EPI)
16. Serum albumin less than or equal to 3.0g/dl
17. Bilirubin greater than or equal to 1.5 mg/dl
18. Aminotransferases levels five time above the Upper Limit of Normal (x5
times the ULN)
19. Any disorder where the patient would not tolerate placement of a dialysis
catheter, blood volume loss during an extracorporeal session or from
research blood draws per the judgment of the principal investigator.
20. Patient refuses to receive blood replacement.
21. History of allergy to heparin or heparin-induced thrombocytopenia.
22. Antibiotic or probiotic use within the 30 days prior to enrollment.
23. History of solid organ transplantation.
24. Any condition which, in the opinion of the investigator, makes the patient
a poor candidate for this clinical trial.
25. Patients may not participate in any other investigational trial while
participating in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified