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a mAbs MF11-30 and Mel-1 were derived from the same hybridoma. b (n) number of patients. c CR = complete response. d MR = minor response. e KLH = keyhole limpet hemocyanin. f BCG = attenuated strain of Mycobacterium bovis. g SAF-m = mixture of chemical and bacterial components. h SD = stable disease.

a mAbs MF11-30 and Mel-1 were derived from the same hybridoma. b (n) number of patients. c CR = complete response. d MR = minor response. e KLH = keyhole limpet hemocyanin. f BCG = attenuated strain of Mycobacterium bovis. g SAF-m = mixture of chemical and bacterial components. h SD = stable disease.

of the anti-id mAb BEC2 as an immunogen to implement active specific immunotherapy in patients with an overexpression of GD3 ganglioside in their malignant lesions. No information is available yet about the results of this multicenter trial.

Additional limitations to be taken into account when analyzing the published results include: (i) the advanced stage of the disease of most of the patients enrolled in clinical trials to evaluate experimental therapies; (ii) the scanty information about the functional characteristics of the immunized patients' immune system; and (iii) the heterogeneity of the immunized patient populations in terms of tumor load and/or prior therapies. In spite of these limitations, the following conclusions can be drawn from the available information in the literature:

(i) Repeated administrations of xenogeneic anti-id antibodies to patients with malignancies have not been associated with side effects in spite of the induction of high titer antibodies to the constant and variable regions of the immunizing antibodies. Results to be reported elsewhere also suggest that antibodies to the constant regions of the immunizing xenogeneic anti-id antibodies do not affect their ability to induce TAA binding anti-anti-id antibodies. These findings argue against the need to reduce the induction of anti-Ig antibodies in immunized patients by utilizing fragments instead of the whole Ig of anti-id antibodies as immunogens. The only side effects experienced by immunized patients have been caused by some of the adjuvants used such as Bacille Calmette Guerin (BCG).

(ii) Most, although not all the anti-id antibodies which have been tested have induced antibodies to the corresponding TAA in a variable percentage of the immunized patients. The difference in patients' ability to develop TAA binding anti-anti-id antibodies may reflect the different extent of immune suppression

Table 5. Immunological and clinical responses in patients with ovarian carcinoma immunized with anti-id mAb mimicking CA125

Anti-TAA mAb Anti-id mAb Carrier and adjuvant Patients # Immune response Clinical response References

OC125 ACA125 - 16 anti-CA125 Abs (9)a Survival prolongation [73]

a (n) number of patients.

Table 6. Immunological and clinical responses in patients with melanoma immunized with anti-id mAb mimicking GD2 or GD3 gangliosides a (n) number of patients.

Table 6. Immunological and clinical responses in patients with melanoma immunized with anti-id mAb mimicking GD2 or GD3 gangliosides

Ganglioside

Anti-TAA mAb

Anti-id mAb

Carrier and adjuvant

Patients #

Immune response

Clinical Response

References

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