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Keep this study
Lead
National Cancer Institute (NCI)
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and Phase II dose of oral penclomedine in patients with malignancies.
II. Determine the toxic effects of oral penclomedine in these patients. III. Determine the pharmacokinetics of oral penclomedine in these patients. IV. Determine the bioavailability of oral penclomedine in these patients.
OUTLINE:
Patients enrolled on the bioavailability portion of this study receive one dose of IV penclomedine over 1 hour followed by 2 weeks of rest. At the end of two weeks, they receive oral penclomedine for 5 days every 28 days. The starting dose is determined by a single primary patient who has been administered oral penclomedine and observed for dose limiting toxicity (DLT). \[Bioavailability portion completed as of 3/98.\] Those not on the bioavailability portion of study start on a standard design dose escalating schedule in which patients enroll in cohorts of 3. Patients are administered oral penclomedine daily for 5 days. This treatment repeats every 4 weeks. The MTD is defined as the dose immediately below that at which 2 patients experience DLT. Treatment repeats for 6 courses or until severe toxicity or tumor progression is observed.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy (solid tumor or lymphoma)
No history of brain metastases
PATIENT CHARACTERISTICS:
Age: 18 and over
Life expectancy: At least 12 weeks
Performance status: ECOG 0-2
WBC at least 4,000/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Bilirubin less than 1.5 mg/dL
Creatinine normal
No history of seizure disorder Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered
At least 4 weeks since prior radiotherapy and recovered
Clareo Health | Penclomedine in Treating Patients With Solid Tumors or Lymphoma