Phase i clinical trials

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The major objective of phase I trials of cytotoxics is determining a dose of the drug or regimen that is safe for use in subsequent clinical studies. For cytotoxics it is assumed that higher doses have greater antitumor effects and so phase I trials are usually designed to estimate the maximal tolerated dose.

Tumor vaccines are often based on DNA constructs, viral vectors, and cytokines that have been determined as safe from previous clinical trials. Peptide vaccines generally seem inherently safe so long as the cytokine adjuvants are used in combinations and doses previously demonstrated to be safe. For example, peptide vaccines based on nonmutated melanoma antigens such as MART-1/Melan A and gp100 were initially evaluated in a phase I trial at the National Cancer Institute at doses ranging from 0.1 to 10 mg. However, no toxicity was encountered even at the highest dose (1,2).

Table 1

Finding the Minimum Active Dose

Table 1

Finding the Minimum Active Dose

Probability of Immunologic Response

Number of Patients Treated at Dose

Probability of No Immunologic Responses

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