CA Protocol '98

IPT Breast, Ovarian, and Lung Cancer Protocol of November, 1998

by SGA, M.D.

[ Following is a summary of the abstract, by C Duffield. ]

[summary of ] ABSTRACT

[Original historical document may be available from Dr. SGA.]

In this protocol, low-dose chemotherapy drugs are given along with insulin and glucose as chemo-hormonal treatment for breast, lung, and ovarian cancer. Insulin acts as a biological response modifier to boost the effects of chemo drugs. Glucose quells the hypoglycemia brought on by the insulin. Insulin and insulin-like growth factor-1 (IGF-1) are known growth factors in breast cancer and some lung cancer cells. Exogenous insulin can alter membrane mechanisms and stimulate cell growth, to potentiate the drug effects. Insulin increases transport of drugs across cancer cell membranes, and recruits cancer cells into S-phase of the growth cycle (where cells are more sensitive to some anticancer drugs) via cross-reaction with IGF-1 receptors. This synergy greatly increases the effectiveness of chemotherapy, and allows reduced doses of the drugs, thus avoiding dose-related side effects. The effect is increased for cancer cells relative to normal cells because of a much higher concentration of insulin receptors on cancer cell membranes, thus increasing cancer cell kill while sparing normal cells. Empirically, this protocol of insulin-potentiated low-dose chemotherapy has produced complete long-term remission in several types of cancer, without toxic side effects from the chemo drugs. This protocol is for a prospective pilot clinical trial on adults with stage IV breast cancer, unresectable ovarian cancer (all stages), and unresectable small-cell lung cancer (all stages). This study will compile outcomes data (survival and disease-free survival, tumor responses, potentiation of anticancer drug effect by insulin, quality of life measurements, changes in biochemical markers of disease). If the results warrant, Phase III randomized clinical trials of IPT can be undertaken.