single-arm study of laparoscopic cytoreduction and HIPEC

Cancer

Minimally-Invasive Procedure

UCSD Moores Cancer Center

A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy

Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.

Individual participant data will be shared with Genelux Corporation

Dr. Kaitlyn J Kelly

Assistant Clinical Professor of Surgery

University of California, San Diego

20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)

IMC-A12 Monotherapy in Patients

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Clinical Response Rate (PR+CR)

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Safety of IMC-A12 in Patients With Mesothelioma

Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Duration of Overall Response

Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Progression Free Survival (PFS)

Overall survival is the time interval from the start of treatment to the date of death.

mesothelioma/carbohydrate

A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

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