Penclomedine in Treating Patients With Solid Tumors or Lymphoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphoma

Treatments: Drug: penclomedine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002946

CDR0000065413 (Registry Identifier)

WCCC-CO-9693

NCI-T96-0067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Arm I

Experimental group

Description:

atients 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.

Treatment:

Drug: penclomedine