Patients selected for these trials are almost always in cancer research centers and have already received all known effective anticancer therapy. After the proposed treatment is explained to them, they may volunteer to receive the new treatment. There is, therefore, no moral objection to giving this new treatment. Since there is "nothing to lose," it is hoped that a specific new agent may in fact prove effective. This phase is completed when no unusual problems or toxic effects have been found and the dose necessary to produce a biologic effect has been determined. The study can then move to the next phase. • Phase II Ten to 20 patients are treated, each with various types of tumors known to be responsive to chemotherapy . These might include lymphomas, breast cancer or colon cancer. Since these tumor types are known to be responsive, the patients will be those who have already received all standard forms of therapy that seem reasonable. The use of a Phase II trial does not deprive anyone of any therapy known to be effective. If a significant number of patients with each type of tumor respond to the therapy, the trial moves to the next level. • Phase III In this phase the new therapy is compared with standard treatment to see if there is an improvement in the response or if the same response rate is achieved but with less-toxic side effects. A therapy tested in a clinical trial does not necessarily involve a drug not already in clinical use. A new treatment often consists of standard drugs used in a new combination or a new sequence, in new dosages or even simply given in a new way. But if a new drug is involved and the Phase III trial is successful, the National Cancer Institute will approve the drug for general use. Eventually, the new therapy might become the standard therapy.