Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Key facts

Study ID

NCT00004079

Run by

National Cancer Institute (NCI)

People needed

46

Starts

1999-08-01

Last updated by the study team

2013-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented malignancy, which is either metastatic or inoperable, for which there is no known curative or standard palliative therapy, or all standard therapeutic approaches have failed
• Patients with leukemia or primary CNS malignancies are excluded; patients with metastatic disease to the CNS, who are not receiving anticonvulsants, including phenytoin, carbamazepine, phenobarbital, primidone, and felbamate, and who have reasonable expectation of surviving long enough to receive two cycles of therapy, are eligible
• Life expectancy of 2 months or longer
• ECOG performance status of 0-2
• Pretreatment laboratory data, obtained within 14 days of study entry, must meet the following criteria:
• ANC >= 1,500 /mm\^3
• Platelets >= 100,000 /mm\^3
• SGOT =< 2.5-times upper limit of normal
• SGPT =< 2.5-times upper limit of normal
• Total bilirubin =< upper limit of normal
• Creatinine =< 1.5 mg/dl
• Creatinine CL >= 60 ml/min (measured 24hr) if creatinine > 1.5 mg/dl
• DLCO >= 80% predicted
• At least 4 weeks since last receiving radiotherapy or chemotherapy and complete recovery from previous treatment related toxicity
• No prior treatment with a nitrosourea or with bleomycin
• No enzyme inducing anticonvulsant agents
• At least 2 weeks since major surgery
• Patients must not have uncontrolled serious medical or psychiatric illness
• Women of childbearing potential must not be lactating or pregnant, because of the proven teratogenicity of other agents of this class; a negative pregnancy test has to be obtained within 2 weeks of entry; both fertile males and females must use adequate contraception upon entry into the study
• Patients must have given signed informed consent

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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