Introduction
Materials and methods
Study design
Patient population
Vaccine production and release criteria
Treatments and efficacy assessments
Toxicity
Correlative studies
Statistical analyses
Results
Patient characteristics
Characteristics | Patients, no. (%) | ||||
---|---|---|---|---|---|
Arm A, 18 (26.1) | Arm B, 20 (29.0) | Arm C, 31 (44.9) | Total patients, 69 (100) | ||
Sex | Male | 11(15.9) | 7 (10.1) | 15 (21.7) | 33 (47.8) |
Female | 7 (10.1) | 13 (18.8) | 16 (23.2) | 36 (52.2) | |
Age, years | Median | 63 | 63 | 63 | 62 |
Range | 43–73 | 51–74 | 48–73 | 43–74 | |
Race | White | 16 (23.2) | 19 (27.5) | 31 (44.9) | 67 (97.1) |
AA/other | 1/1 (2.9) | 0/0 (0.0) | 0/0 (0.0) | 1/1 (2.9) | |
ECOG PS | 0 | 4 (5.8) | 6 (8.7) | 4 (5.8) | 14 (20.3) |
1 | 14 (20.3) | 14 (20.3) | 27 (39.1) | 55 (79.7) | |
Chemotherapy | ≤ 4 cycles | 5 (7.2) | 6 (8.7) | 4 (5.8) | 15 (21.7) |
> 4 cycles | 13 (18.8) | 14 (20.3) | 27 (39.1) | 54 (78.3) | |
Radiotherapy | PCI | 5 (7.2) | 6 (8.7) | 3 (4.3) | 14 (20.3) |
WBRT | 2 (2.9) | 0 (0.0) | 7 (10.1) | 9 (13.0) | |
Thoracic | 6 (8.7) | 4 (5.8) | 4 (5.8) | 14 (20.3) | |
Distant | 2 (2.9) | 3 (4.3) | 5 (7.2) | 10 (14.5) | |
Leukapheresis | Total (patients) | 18 (26.1) | 31 (44.9) | 49 (71.0) | 62 (100) |
Total (quantity) | 24 (38.7) | 38 (61.3) | |||
0/1 | 2/12 (20.3) | 0/24 (34.8) | 2/36 (55.1) | ||
2 | 6 (8.7) | 7 (10.1) | 13 (18.8) | ||
Vaccination, No | Median | 3 | 3 | 3 | |
Range | 0–6 | 1–6 | 0–6 | ||
< 3/3/> 3 | 4/12/4 (29.0) | 5/19/7 (44.9) | 9/31/11 (73.9) | ||
Total | 59 (36) | 105 (64) | 164 (100) |
Safety
Ad.p53-DC vaccines + ATRA (n = 31) | Ad.p53-DC vaccines (n = 20) | Total (N = 51) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
G1/G2 |
G3
| Total | % | G1/G2 |
G3
| Total | % |
%
| ||
Laboratory, metabolic/chemistry | ||||||||||
Sodium, serum-low (hyponatremia) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Laboratory, hematologic
| ||||||||||
Hemoglobin | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
Neutrophils/granulocytes | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
Platelets | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Constitutional
| ||||||||||
Anorexia | 5 | 5 | 16.13 | 2 | 2 | 10.00 | 7 | 13.73 | ||
Fatigue (asthenia, lethargy, and malaise) | 9 | 1 | 10 | 32.26 | 2 | 1 | 3 | 15.00 | 13 | 25.49 |
Edema (limb, head, and neck) | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 | ||||
Respiratory
| ||||||||||
Cough | 3 | 3 | 9.68 | 1 | 1 | 5.00 | 4 | 7.84 | ||
Dyspnea (shortness of breath) | 5 | 1 | 6 | 19.35 | 2 | 2 | 10.00 | 8 | 15.69 | |
Hypoxia | 0.00 | 1 | 1 | 5.00 | 1 | 1.96 | ||||
Gastrointestinal
| ||||||||||
Constipation | 3 | 3 | 9.68 | 1 | 1 | 5.00 | 4 | 7.84 | ||
Diarrhea | 6 | 6 | 19.35 | 0.00 | 6 | 11.76 | ||||
Nausea | 8 | 1 | 9 | 29.03 | 1 | 1 | 5.00 | 10 | 19.61 | |
Vomiting | 6 | 1 | 7 | 22.58 | 0.00 | 7 | 13.73 | |||
Neurologic/psychiatric | ||||||||||
Pain/headache | 19 | 3 | 22 | 70.97 | 0.00 | 22 | 43.14 | |||
Neuropathy (sensory/motor) | 1 | 1 | 3.23 | 3 | 3 | 15.00 | 4 | 7.84 | ||
Mood alterations (agitation, anxiety, depression, and euphoria) | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
Cutaneous
| ||||||||||
Injection site reaction/extravasation changes | 2 | 2 | 6.45 | 3 | 3 | 15.00 | 5 | 9.80 | ||
Rash (desquamation, acneiform, treatment associated, and hay fever reaction) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Dry skin | 4 | 4 | 12.90 | 0.00 | 4 | 7.84 | ||||
Pruritus/itching | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Hair loss/alopecia (scalp or body) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Musculoskeletal
| ||||||||||
Pain (arthralgia/myalgia) | 3 | 3 | 9.68 | 0.00 | 3 | 5.88 | ||||
Pain
| ||||||||||
Abdominal and not otherwise specified | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 | ||||
Back and neck | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
Extremities and limbs | 2 | 2 | 6.45 | 1 | 1 | 5.00 | 3 | 5.88 | ||
Other | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
Miscellaneous
| ||||||||||
Urinary retention (including neurogenic bladder) | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 |