Fever-range whole-body thermal therapy combined with cisplatin, gemcitabine, and daily interferon-α: A description of a phase I-II protocol

Figures & data

Figure 1. (a) The HT2000 infrared radiant heat device being closed. (b) HT2000 infrared radiant heat device with heating lights off, and soft tent sides folded over patient.

Table I.  Tumor diagnosis of individual patients, age, sex, race, stage, number of treatment cycles, response, time to tumor progression (duration in months), and prior therapy.

Diagnosis	Age	M/F	Race*	Stage	No. of cycles	Response	Duration (months)	Prior therapy
Pancreas	57	F	C	IV	3	PD	-	none
	62	F	C	III	3**	PR	9	gemcitabine, carboplatin
	74	F	AA	IV	2	PR	10	cisplatin/gemcitabine,
	64	M	C	III	2**	PR	6	cisplatin/gemcitabine
	61	M	C	IV	2	PR	7	radiation, gemcitabine, gene therapy
	70	F	C	IV	3	SD	4	gemcitabine
	55	M	AA	IV	3	PR	7	gemcitabine
Neuroendocrine	59	M	AA	III	2	PR	5	gemcitabine, carboplatin
	40	F	AA	IV	8	PR	10	cisplatin,/gemcitabine, irinotecan
	66	F	C	IV	4	CR	42	cisplatin/etoposide, paclitaxel
	56	M	AA	IV	1	PR	4	carboplatin/paclitaxel
	56	M	C	IV	8**	PR	15	cisplatin, leuprolide, bicalutamide
	63	M	C	III	5	PR	20	cisplatin, paclitaxel, taxotere, etoposide
Gastric	67	M	C	IV	1	PD	-	gemcitabine, capecitabine, 5-FU/irinotecan,
	64	M	C	IV	2	PR	5	Cisplatin/gemcitabine, doxorubicin
	47	F	H	IV	1	PD	-	doxorubicin/5-FU
	45	M	C	IV	2	PD	-	doxorubicin, etoposide
Lung	59	M	C	IV	2	PD	-	carboplatin/paclitaxel; vinorelbine, topotecan
	63	F	C	IV	1	PD	-	carboplatin/paclitaxel; topotecan
	50	M	C	IV	3	PR	8	radiation, carboplatin/paclitaxel, vinorelbine
Colon	51	M	C	IV	3	SD	4	5-FU/leucovorin; capecitabine/irinotecan
	46	M	AA	IV	3	PD	-	gemcitabine, carboplatin/5-FU/leucovorin, irinotecan
	71	F	C	IV	1	PD	-	radiation, oxaliplatin, capecitabine, 5-FU\/levamsole
Breast	54	F	C	IV	2**	PR	5	gemcitabine, 5-FU/dox/cyclophsphamide, paclitaxel, vinorelbine, Doxil
	47	F	C	IV	2	PD	4	gemcitabine, 5-FU/doxorubicin/cyclophosphamide, paclitaxel, vinorelbine, capecitabine
Prostate	72	M	C	IV	1	PD	-	leuprolide, diethylstilbestrol, taxotere
	77	M	C	IV	1	SD	2	radiation, gemcitabine, capecitabine, leuprolide, genetherapy, diethylstilbesterol, iressa/docetaxel/thalidomide
Esophagus	73	M	C	IV	1	PD	-	cisplatin/5-FU
	56	M	C	IV	3	PR	5	radiation, irinotecan,
AUP*	66	F	C	IV	1	PD	-	cisplatin/gemcitabine, doxorubicin/cyclophosphamide
	46	F	AA	IV	1	PD	-	carboplatin/paclitaxel, doxorubicin, Doxil
Sarcoma	26	F	C	IV	5	PR	14	gemcitabine, vinblastine, thalidomide, BCNU, mesna/doxarubicin/ifosfamide/dacarbazine
Liver	33	M	C	IV	3	SD	5	cisplatin/gemcitabine, capecitabine/doxorubicin,
Hear & Neck	47	M	C	III	2**	SD	3	cisplatin/5-FU
Kidney	71	M	C	IV	3	SD	5	gemcitabine, paclitaxel
Bladder	57	M	H	IV	2	SD	4	cisplatin, interferon-alpha
Mesothelioma	78	M	C	IV	2	PD	-	cisplatin/paclitaxel, progesterone

*C, Caucasian; AA, African American; H, Hispanic; **adenocarcinoma unknown primary; ***treatment terminated because of 9 week facility closure for flood damage.

Table II.  Toxicities per cisplatin dose: Hematological and non-hematological.

Toxicity	Cisplatin dose	Grade	Number/dose
Leukopenia	Cisplatin 40 mg/m^2	I	1/3
	Cisplatin 50 mg/m^2	I	1/3
	Cisplatin 60 mg/m^2	I	9/29
	Cisplatin 60 mg/m^2	II	16/29
	Cisplatin 70 mg/m^2	II	2/2
Thrombocytopenia	Cisplatin 40 mg/m^2	-	0/3
	Cisplatin 50 mg/m^2	-	0/3
	Cisplatin 60 mg/m^2	I	18/29
	Cisplatin 60 mg/m^2	II	6/29
	Cisplatin 70 mg/m^2	II	2/2
Anemia	Cisplatin 40 mg/m^2	I	1/3
	Cisplatin 50 mg/m^2	I	1/3
	Cisplatin 60 mg/m^2	I	15/29
	Cisplatin 60 mg/m^2	II	6/29
	Cisplatin 70 mg/m^2	II	2/2
Renal	Cisplatin 40–70 mg/m^2	0	0/37
Neuropathy	Cisplatin 40–50 mg/m^2	0	0/6
	Cisplatin 60 mg/m^2	I	2/29
	Cisplatin 60 mg/m^2	II	1/29
	Cisplatin 70 mg/m^2	III	2/2
Ototoxicity	Cisplatin 40–60 mg/m^2	0	0/35
	Cisplatin 70 mg/m^2	III	1/2
Nausea	Cisplatin 40–50 mg/m^2	0	0/6
	Cisplatin 60 mg/m^2	I	5/29
	Cisplatin 60 mg/m^2	II	1/29
	Cisplatin 70 mg/m^2	I	1/2
Diarrhea	Cisplatin 40–70 mg/m^2	0	0/37
Pressure injury	Cisplatin 40 mg/m^2	I	1/3
	Cisplatin 50 mg/m^2	I	1/3
	Cisplatin 60–70 mg/m^2	0	0/2
Burn	Cisplatin 40–50 mg/m^2	0	0/6
	Cisplatin 60 mg/m^2	II	1/29
	Cisplatin 70 mg/m^2	0	0/2

Table III.  Tumor response by cisplatin dose (40–70 mg/m²) evaluated using response evaluation criteria in solid tumors (RECIST).

Response	Cisplatin dose	Number treated	Number of responses	% response
Complete response (CR)	60 mg/m^2	29	1	3%
Total CR		37	1	1/37 = 3%
Partial response (≥50%) (PR)	40 mg/m^2	3	2	67%
	50 mg/m^2	3	1	33%
	60 mg/m^2	29	12	41%
Total PR		37	15	15/37 = 41%
Stable disease (>3 months)(SD)	50 mg/m^2	3	1	33%
	60 mg/m^2	29	6	21%
Total SD		37	7	7/37 = 19%
Progressive disease (PD)	50 mg/m^2	3	2	67%
	60 mg/m^2	29	10	34%
	70 mg/m^2	2	2	100%
Total PD		37	14	14/37 = 38%
Total responses (CR + PR)	All doses	37	16	16/37 = 43%

Figure 2. A Kaplan-Meier plot of time to tumor progression.

Figure 3. A Kaplan-Meier plot of overall survival.