Protocol Number: 02-AT-0260
Patients 18 years of age or older with pancreatic, colorectal, lung, or breast cancer that cannot be surgically removed, has recurred, or has spread beyond the primary site may be eligible for this study. Patients with lung and pancreatic cancer may be enrolled whether or not they have previously received chemotherapy; patients with breast and colorectal cancer must have received first-line chemotherapy without being cured, before being eligible for this study. Participants will receive test medications as follows: - Gemcitabine will be prescribed in a standard regimen as it would be indicated for any cancer patient in an outpatient oncology clinic. Gemcitabine will be administered in 3-week cycles as follows: day 1 of the first week and day 1 of the second week, with no infusion given the third week. The drug is given in 30-minute infusions through a catheter (thin plastic tube) placed in an arm vein. - Mistletoe extract will be administered as an injection under the skin on the abdomen once a day every day starting with the second gemcitabine infusion. Patients will be taught how to self-administer the injections. There are two treatment stages. In the first stage, all patients will receive the same dose of gemcitabine. The mistletoe dose will vary, with groups of three patients receiving increasingly higher doses of the extract. In the second stage, the gemcitabine dose will be increased in groups of three patients until side effects are no longer tolerated, at which point the dose will be lowered. The mistletoe dose will not vary for patients enrolled in stage two of the study. Participants will have the following tests and procedures: - Blood tests - On the day of the first gemcitabine treatment, blood samples will be drawn before and several hours after the infusion to measure how much of the drug gets into the body and how long it stays in the body. This test will be repeated about 6 to7 weeks after starting mistletoe treatment to see what effect the mistletoe has on the length of time gemcitabine remains in the body. Several times during the study, blood samples will be collected to test immune system functions and to determine whether genes in certain immune system cells become active during treatment. - Scans and X-ray studies - Imaging studies will be done every 3 treatment cycles (about every 9 weeks) to examine the response of the tumor to treatment.
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