Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients

Inclusion Criteria:

Patients in both treatment groups must meet all of the following criteria to be considered eligible to participate in the study:

Adult men or women, aged 18 years or older, with histologically-confirmed, metastatic adenocarcinoma of the colon or rectum that has been proven to be resistant to available treatment options, including at least 2 such options from available chemotherapy, targeted, and/or other regimens.
Radiographic evidence of disease progression.
Life expectancy of at least 6 weeks, in the investigator's opinion, at the time disease progression is documented.
Considered surgical candidates on the basis of co-morbidity risks, number and sites of metastases, and ability to undergo general anesthesia.
Able to understand the risks of experimental therapy and provide written consent by signing the appropriate form.

Patients in Group A must also meet all of the following additional criteria:

ECOG performance status score of 0, 1, or 2.

Adequate hematologic function, defined as follows:

absolute neutrophil count (ANC) ≥1500 /mL
hemoglobin ≥9 g/dL
platelets ≥75,000 /mL

Adequate hepatic function, defined as follows:

bilirubin ≤1.5 times the upper limit of normal (x ULN)
aspartate transaminase (AST) ≤3 x ULN, or ≤5 x ULN if liver metastases are present
alanine transaminase (ALT) ≤3, x ULN, or ≤5 x ULN if liver metastases are present
Adequate renal function, defined as creatinine ≤2.0 mg/dL.

Adequate coagulation function, defined as follows:

International Normalized Ratio (INR) ≤1.5 or between 2 and 3 if the patient is receiving anticoagulation
Partial Thromboplastin Time (PTT) ≤5 seconds above the ULN Note: Patients receiving full-dose anticoagulation therapy must have received a stable dose of oral anticoagulant therapy or low-molecular-weight heparin.
Clinically significant toxic effects of chemotherapy (excluding alopecia), radiotherapy, hormonal therapy, or prior surgery must have resolved to Grade 1 or better, with the exception of peripheral neuropathy, which must have resolved to Grade 2 or better.
Female participants of childbearing potential must have had a negative serum pregnancy test at screening; and must also agree to contraceptive use while on study if sexually active. Male subjects and their partners must have agreed to use condoms.

Exclusion Criteria:

Patients in either treatment group who meet any of the following criteria will be excluded from participating in the study:

Hepatic blood flow abnormalities, i.e., portal vein hypertension and thrombosis, and/or a large volume of ascites.
Concurrent cancer of any other type, except skin cancers other than melanoma.
A positive test result for HIV or any hepatitis other than A at screening.
Considered by the investigator to be unsuitable for participation in the study upon review of medical history, physical examination, or clinical laboratory test results.

Patients in Group A who meet any of the following criteria will be excluded from participating in the study:

Received FDA-approved chemotherapy within 3 weeks of Day 0, or bevacizumab (or similar drugs) within 4 weeks of Day 0, or radiation therapy at any site within 4 weeks of Day 0.
Investigational anticancer therapy within 4 weeks of Day 0.
Positive reaction to the skin test for allergy to mouse antigen.
History of hypersensitivity reaction that, in the opinion of the investigator, poses an increased risk of an allergic reaction to the RENCA macrobeads, particularly any known allergy to murine antigens or body tissues.
Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias (with the exception of well controlled atrial fibrillation), active bleeding, or psychiatric illness, or social situations that could interfere with the patient's ability to participate in the study.