Dose and Schedule of Administration

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Five vaccine dosage schedules have been tested and are summarized in Table 2. The animal tumor models, particularly the paper of Fujiwara et al. (32), prompted us to presensitize patients with DNFB by topical application of a 1% solution in acetone-corn oil, and this was done in schedules A, B, and C. Subsequently, the presensitization was found to be unnecessary (but not deleterious) for the induction of maximum DTH to autologous melanoma cells and it was omitted for schedules D and E.

For schedule A, DNP-vaccine mixed with BCG was administered every 4 wk for a total of eight doses; cyclophosphamide 300 mg/M2 was administered 3 d before the first and second doses. All vaccine injections were given in the same site on a limb (usually the upper dorsal arm) that had not been subjected to a lymph node dissection. For schedule B, vaccine was administered weekly for 6 wk; after a 4-wk reevaluation period vaccine was again administered weekly for 6 wk. The first three vaccines of each course were DNP modified and the last three were unmodified. BCG was admixed only with the first and fourth vaccine of each course. All of the DNP-vaccine injections were given into one area, and all of the unmodified vaccine injections were given into a second area. Cyclophos-phamide 300 mg/M2 was administered 3 d prior to the start of each vaccine course. Schedule C was identical to schedule B, except that all vaccines were DNP modified and all were mixed with BCG. Schedules D and E were simplified regimens in which DNFB presensitization was omitted and only one series of six weekly DNP-modified vaccines was administered; these schedules differed only by dose ranges: D = 2.5 - 7.5 x 106 vs E = 0.5 - 2.0 x 106 intact tumor cells per dose.

Table 3

Summary of Patients Treated With DNP-Modified Autologous Vaccine

Melanoma: 1) Measurable metastases 97a

2) Postsurgical adjuvant, stage III 214a

3) Postsurgical adjuvant, stage IV 20

4) Postsurgical adjuvant, low dose 76 Total 407


Carcinoma: 30

Renal Cell Carcinoma:

Total: 447

^Clinical and immunological results discussed in text.

Only immunological results discussed in text.

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