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Protocol Number: 03-C-0152 
Patients 18 years of age and older with cancer that cannot be treated successfully with standard therapy may be eligible for this study. Patients with cancers of the blood and lymph system and patients with primary lung cancer are excluded. Candidates are screened with a medical history, physical and eye examinations; blood tests; electrocardiogram (EKG) and MUGA (nuclear medicine test of heart function); chest x-ray; chest, abdomen, and pelvic CT or MRI scans; and other studies as needed to evaluate their disease. Participants receive an injection of "CYT 99 07" under the skin every other day for 2 consecutive weeks, for a total of eight doses. The dose of the drug is increased gradually in groups of three patients for up to five increases as long as unacceptable side effects do not develop at the previous dose. All patients receive the first injection in the hospital. Depending on an individual patient's side effects, subsequent injections may be given on an outpatient basis, or the patient may need to stay in the hospital for several days or for the entire course of treatment. In addition to "CYT 99 07" injections, patients undergo the following tests and procedures during treatment: -Daily evaluations for signs of drug toxicity during the 2-week treatment period, examinations by a doctor at least once a week, and blood draws before each injection and every 3 or 4 days for routine monitoring. -Days 1 and 14 (the days of the first injection and last injection of "CYT 99 07"): multiple blood draws to see how the drug circulates in the body. Blood is drawn before the injection and then at 30, 60, and 90 minutes and 2, 4, 8, 12, and 24 hours after the injection. Patients are hospitalized for at least 24 hours for the multiple blood draws. -Day 7: EKG and chest x-ray. -Day 14: Bone marrow biopsy. Another biopsy may be done up to 2 months after treatment to evaluate the effects of "CYT 99 07" on bone marrow production. -Day 16: Urinalysis, EKG, chest x-ray, and CT scan (special x-ray exam to evaluate the extent of disease) -Day 21: Urinalysis, EKG, and chest x-ray. -Day 28: Eye examination, urinalysis, EKG, chest x-ray, and CT scan; and possibly MRI (test that uses a magnetic field and radio waves instead of x-rays to provide detailed pictures of internal organs) Patients who show abnormalities in their physical examinations or laboratory studies may be asked to return for blood tests beyond the 28-day study period to follow the course of the abnormalities. They may also be asked to return for evaluation and blood tests 3 and 6 months after completing treatment to check for long-term effects of treatment.
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National Institutes of Health Clinical Center