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A PHASE I AND PHARMACOLOGICAL STUDY OF PENCLOMEDINE (NSC#338720, IND#43409) ADMINISTERED DAILY BY MOUTH FOR FIVE CONSECUTIVE DAYS IN PATIENTS WITH ADVANCED SOLID TUMOR MALIGNANCIES


Phase 1
19 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A PHASE I AND PHARMACOLOGICAL STUDY OF PENCLOMEDINE (NSC#338720, IND#43409) ADMINISTERED DAILY BY MOUTH FOR FIVE CONSECUTIVE DAYS IN PATIENTS WITH ADVANCED SOLID TUMOR MALIGNANCIES


OBJECTIVES: I. Determine the maximum tolerated dose of oral penclomedine that can be
administered daily for 5 days every 4 weeks in patients with advanced solid tumor
malignancies. II. Describe and quantitate the toxic effects of penclomedine administered on
this schedule in these patients. III. Study the clinical pharmacology and metabolism of
penclomedine on this schedule, and seek pharmacodynamic correlates of pharmacologic
parameters with clinical endpoints. IV. Study the bioavailability of oral penclomedine, and
qualitatively compare metabolite profiles produced following oral and intravenous
administration in these patients. V. Seek preliminary evidence of therapeutic activity of
penclomedine in patients with advanced cancer.

OUTLINE: This is a dose-escalation study to estimate the maximum tolerated dose (MTD) of
penclomedine. Cohorts of 3-6 patients are treated at escalating doses until the MTD is
reached. Patients receive oral penclomedine for 5 consecutive days every 4 weeks. If tumor
progression or unacceptable toxicity is documented during any treatment course, the patient
is removed from study. A total of 10 patients will be treated at the dose determined to be
the MTD (the recommended phase II dose).

PROJECTED ACCRUAL: An estimated 20 patients will be accrued over approximately 10 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically documented solid tumor that is
refractory to conventional therapy or for which no conventional treatment exists No
primary or secondary brain tumor No CNS disease or treatment-related CNS dysfunction No
bone metastases involving 4 or more sites

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,500 Platelet count
greater than 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no
greater than 1.5 mg/dL Other: No active infection No history of egg protein allergy No
prior gastric or small intestine resection or clinical evidence of malabsorption No
history of medical, neurologic, or psychiatric disorder No concomitant medical problem
unrelated to the malignancy that precludes study compliance or increases treatment risk No
pregnant women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
more than 4 courses of combination chemotherapy that included an alkylating agent,
cisplatin, or carboplatin (applies once grade 1 or worse myelosuppression is reported on
this study) No prior mitomycin or nitrosoureas At least 28 days since chemotherapy No
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy to wide ports involving pelvis or 20% of bone marrow At least 28 days since
large-field radiotherapy No concurrent radiotherapy Surgery: At least 14 days since major
surgery Other: No bone marrow transplantation

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross C. Donehower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065290

NCT ID:

NCT00002915

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287