Penclomedine in Treating Patients With Solid Tumors or Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase I Trial of Oral Penclomedine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002946
• Other study ID #: CDR0000065413
• Secondary ID: WCCC-CO-9693NCI-
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 8, 2013
• Start date: October 1997

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase I trial to study the effectiveness of penclomedine in treating patients with malignant solid tumors or lymphomas. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• penclomedine

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,