Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared to Best Supportive Care in Colorectal Cancer Patients
Condition: Colorectal Cancers
MeSH terms: Colorectal Neoplasms
Intervention: RENCA macrobeads
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colon; colorectal; rectal; cancer; macrobead; stage IV; metastatic; biological; mouse cells; new york; new jersey; clinical research

Summary:

      This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for
      patients with advanced colorectal cancer that no longer responds to standard therapies.

      The treatment is being evaluated for its effect on tumor growth. It consists of the placement
      (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA
      macrobeads). The cells in the macrobeads produce substances that have been shown to slow or
      stop the growth of tumors in experimental animals and veterinary patients. It has been tested
      in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II
      studies in patients with colorectal, pancreatic or prostate cancers are in progress
    

Eligibility criteria:

        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:

               1. absolute neutrophil count (ANC) ≥1500 /mL

               2. hemoglobin ≥9 g/dL

               3. platelets ≥75,000 /mL

          -  Adequate hepatic function, defined as follows:

               1. bilirubin ≤1.5 times the upper limit of normal (x ULN)

               2. aspartate transaminase (AST) ≤3 x ULN, or ≤5 x ULN if liver metastases are
                  present

               3. 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:

               1. International Normalized Ratio (INR) ≤1.5 or between 2 and 3 if the patient is
                  receiving anticoagulation

               2. 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.