Results of a Phase I Clinical Study Using Dendritic Cell Vaccinations for Thyroid Cancer

DC therapy

DC therapy

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Summary

This study investigated the feasibility and efficacy of dendritic cell (DC) therapy for advanced thyroid papillary and follicular cancer. The results suggested, DC immunotherapy could be administered to patients with thyroid papillary or follicular cancer with no side effects.

Patients characteristics

6 patients were histologically proven to have thyroid cancer with distant metastases. Patients (2 men and 4 women; aged 46–72 years, mean 60 years) who had previously undergone thyroidectomy.

Methodology

Tumor lysates extraction
Tumor lysates were used as a tumor antigen. To prepare the lysates, tumor mass was obtained by surgery from each patient. The isolated mass was then homogenized in PBS and filtered through BD Falcon cell strainer with 100mm mesh, and tumor cell suspensions were obtained. Aliquots of the isolated tumor cells (107 cells/tube) were then lysed by putting them through 3 freeze (in liquid nitrogen) and thaw (in a 37 C water bath) cycles. The lysed cells were centrifuged at 12,000rpm for 5 minutes at RT. Aliquots (300 mg/tube) were then stored at – 135 C until use.
Preparation of the DC
iDCs (>107 cells/dish) in plastic dishes were cultured for 24 hours in 3 ml of medium containing 100 mg/ml of autologous tumor lysates. After 7 ml of the complete medium containing 50 ng/ml (final) of rhTNFa was added to the medium, the loaded cells were subsequently cultured for another 4 days to develop into mDCs.

Treatment

Patients were injected intracutaneously with tumor lysate-pulsed monocyte-derived mDCs (107 cells/ injection) in close proximity to the cervical, axially, or inguinal lymph nodes. Low-dose (350 KIU) interleukin-2 was also administered for 3 days at each vaccination.

Results

During the therapeutic protocol, no clinical adverse events were observed, including serological induction of auto- immunity, fever, or local skin inflammation at vaccination sites. No sign of NCI-CTC grade 3–4 toxicity was evident following DC-based vaccination.
Following the 5–16 vaccinations, 4 patients exhibited progressed disease (PD) response and 2 (both of them suffered from papillary thyroid cancer) showed stable disease (SD) response during the immunotherapy.
1 patient with lung metastasis, calculated form CT images. Tumor growth rate appeared to be reduced during DC therapy. Similar analysis of other patient with lymph node metastasis also revealed inhibition of tumor growth
DTH response
Irradiated autologous thyroid cancer cells and their lysates were injected intradermally in each patient’s forearm, both before and after treatment. Other than a minor response noted for patient 6 on the secondDTH skin test performed after the 8th vaccination, no significant DTH responses were observed in any of the patients.

Conclusion

DC immunotherapy could be administered to patients with thyroid papillary or follicular cancer without substantial side effects.

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Scientific article publishing date: 11/1/2007

Immucura identifier BSC21_326EN

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