KRN5500 in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors. Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer cells from dividing so they stop growing or die

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: KRN 5500

Criteria

Inclusion Criteria:

• Metastatic or inoperable malignancy, other than leukemia or a primary CNS tumor, for which there is no known curative or survival prolonging palliative therapy, or all such therapies have failed

• Life expectancy >= 2 months

• ECOG performance status =< 2

• WBC >= 3,000/mm^3

• ANC >= 1,500/mm^3

• Platelets >= 100,000/mm^3

• SGOT ≤ 2.5-times the upper limit of normal (ULN)

• SGPT ≤ 2.5-times the ULN

• Total bilirubin ≤ 1.5 mg/dl

• Serum creatinine ≤ 1.5 mg/dl

• ECG showing no evidence of acute ischemia or serious conduction abnormality

• >= 2 weeks since major surgery

• >= 3 weeks since chemotherapy or radiation therapy, except for nitrosoureas and mitomycin-C, in which case the interval shall be 6 weeks

• Women of childbearing potential must not be pregnant or lactating; all women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L of β-HCG) within 72 hr prior to receiving the study medication; KRN5500 has antiproliferative effects which may be harmful to the developing fetus or nursing infant

• Fertile males and females must use adequate contraception

• Central venous catheter placed at least one day prior to treatment

• Signed informed consent

Exclusion Criteria:

• A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive study treatment

• Uncontrolled or significant pulmonary or cardiovascular disease, including a recent (6 months or less) myocardial infarction, any significant degree of congestive heart failure with or without medical treatment, any history of clinically significant atrial or ventricular arrhythmias, any history of second or third degree heart block, or prolonged QTc interval (greater than 450 ms) on electrocardiogram

• Active brain metastases including evidence of cerebral edema by CT scan or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms related to brain metastases

• A psychiatric illness that precludes the ability to provide informed consent