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An Update of a Phase II Clinical Trial using Fever-Range Whole-Body Thermal Therapy (FR-WB-TT) + Cisplatin (CIS) + Gemcitabine (GEM) + Metronomic, Low-Dose Interferon-a (IFN-a) for Inoperable or Metastatic Pancreas Cancer
J. M. Bull, G. L. Scott, G. Figueroa, S. Tompte, T. Danczak, F. R. Strebel, D. H. Oliver, M. D. Redwine, S. M. Koch;
The University of Texas Medical School at Houston, Houston, TX.
Background: Preclinical studies demonstrated efficacy of a schedule-optimized thermochemotherapy regimen combining FR-WB-TT with CIS/GEM. A Phase I-II trial based on this regimen showed clinical efficacy, and led to a Phase II trial in patients with metastatic and advanced inoperable pancreas cancer. Methods: To date we have treated 17 patients with metastatic pancreas cancer using a phase II clinical protocol therapy. The treatment regimen uses an explicitly sequenced combination of FR-WB-TT (6h at 40ºC) with CIS (60 mg/m2), GEM (600 mg/m2), and daily metronomic, low-dose IFN-a (1 x 106 i.u.). CIS is administered with appropriate hydration and antinausea medication on day 1, thirty-six hours prior to induction of FR-WB-TT + simultaneous GEM. Subcutaneous metronomic IFN-α is begun on day 1 and continued for the duration of the protocol. Results: To date, the number of treatments ranges from 1-6 (median 4) in the 17 patients. Nine patients had received prior chemotherapy; eight received no prior chemotherapy. We observed no neuropathy or ototoxicity. In the 17 patients we documented grade 2 leukopenia in fourteen patients, grade 3 thrombocytopenia in eight patients, and grade 2 thrombocytopenia in five patients. Thirteen patients developed grade 2 anemia. Two patients are too early to evaluate for response. In the 15 patients evaluable for response we documented 1 complete response (7%), 4 partial responses (27%), 5 objective responses (33%), 2 patients with stable disease (13%), and 3 patients with progressive disease (20%) for a 67% overall response (CR + PR + OR). The median duration of response was 7 months (range or 3 to 14 months). Although not formally documented, responding patients experienced increased quality of life. Of interest, four patients who had been heavily pretreated experienced meaningful tumor responses, including the patient achieving CR. Conclusion: While too early to make definitive conclusions, the multimodality FR-WB-TT regimen appears to be well tolerated, and demonstrates clinical activity. This protocol continues to accrue patients with advanced inoperable and metastatic pancreas cancer.
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