The objective of this Phase II study is the clinical evaluation of a novel folate-targeted radiopharmaceutical, 111In-DTPA-folate, for radionuclide imaging.
The Specific Aims are: 1) To generate 111In-DTPA-folate radiopharmaceutical kits manufactured and packaged in accordance with cGMP requirements; 2) to conduct a phase I/II clinical study in ovarian cancer patients to evaluate the safety and possible efficacy of 111In-DTPA-folate for imaging primary and metastatic ovarian carcinoma; 3) to initiate a Phase I/II clinical study in lung adenocarcinoma cancer patients to evaluate the safety and possible efficacy of 111In-DTPA-folate for imaging primary and metastatic lung adenocarcinoma; 4) compilation and analysis of Phase I and Phase II data integrated with market analysis to reach a decision whether proceeding to Phase III clinical trials is scientifically and commercially merited. Studies on Aims 1 will be performed at cGMP production and packaging facilities; studies on Aim 2 will be performed at the University of Texas MD Anderson Cancer Center; and studies on Aim 3 will be performed at the University of Chicago Medical Center. These studies are designed to evaluate the clinical potential of 111In-DTPA- folate as a radionuclide imaging agent for folate receptor positive tumors.
