Phase 1
N=31
Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
Intraabdominal Cancers (Various Types)
Bottom Line
View on ClinicalTrials.gov: NCT00283075 ↗Enrolled (actual)
31
Serious AEs
64.5%
Results posted
Mar 2016
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of RENCA Macrobeads — NA RENCA Macrobeads/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cancer Macrobead placement in abdominal cavity (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Rogosin Institute
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of RENCA Macrobeads |
NA | — |
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0 | — |
| SECONDARY Overall Survival |
5.4; 7.0; 1.1; 5.7 | — |
Summary
This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a proposed biological treatment of patients with end-stage, treatment-resistant cancer. The macrobeads have been extensively tested in tumor models in mice and rats, as well as in forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor responses and no significant detectable toxicity.
Eligibility Criteria
Inclusion Criteria
- End-stage, treatment resistant epithelial-derived cancer (carcinoma) arising originally within the abdominal cavity with expected minimum six-month survival
Exclusion Criteria
- Multiple intraabdominal metastases or carcinomatosis or other medical conditions indicating that the procedure would be of too high a risk for the individual
Data sourced from ClinicalTrials.gov (NCT00283075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.