Penclomedine in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00002915
First received: November 1, 1999
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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 who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: penclomedine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Study Start Date: December 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002915

Locations
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002915     History of Changes
Other Study ID Numbers: CDR0000065290, P30CA006973, JHOC-9637, NCI-T96-0031
Study First Received: November 1, 1999
Last Updated: August 5, 2010
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Penclomedine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014