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Penclomedine in Treating Patients With Solid Tumors or Lymphoma

This study has been completed.

Sponsors and Collaborators: University of Wisconsin, Madison
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002946
  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 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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Trial of Oral Penclomedine

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1997

Detailed 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.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002946

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792

Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)

Investigators
Study Chair:     George Wilding, MD     University of Wisconsin, Madison    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma  
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  
unspecified adult solid tumor, protocol specific  
stage I grade 1 follicular lymphoma  
stage I grade 2 follicular lymphoma  
stage I grade 3 follicular lymphoma  
stage I adult diffuse small cleaved cell lymphoma  
stage I adult diffuse mixed cell lymphoma  
stage I adult diffuse large cell lymphoma  
stage I adult immunoblastic large cell lymphoma  
stage I adult lymphoblastic lymphoma  
stage I adult Burkitt lymphoma  
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma

Study placed in the following topic categories:
Hodgkin's disease
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Penclomedine
Lymphoma, large-cell, immunoblastic
Central nervous system lymphoma, primary
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Burkitt Lymphoma
B-cell lymphomas
Leukemia, T-Cell
Anaplastic large cell lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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