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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002946 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of penclomedine in treating patients with malignant solid tumors or lymphomas.
Condition | Intervention | Phase |
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: penclomedine |
Phase I |
MedlinePlus related topics: | Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
ChemIDplus related topics: | Penclomedine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of Oral Penclomedine |
Study Start Date: | October 1997 |
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.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 Hematopoietic: WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine normal Other: No history of seizure disorder Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
United States, Wisconsin | |||||
University of Wisconsin Comprehensive Cancer Center | |||||
Madison, Wisconsin, United States, 53792 |
University of Wisconsin, Madison |
National Cancer Institute (NCI) |
Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065413, WCCC-CO-9693, NCI-T96-0067 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002946 |
Health Authority: | United States: Federal Government |
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