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Penclomedine in Treating Patients With Solid Tumors or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002946
Recruitment Status : Completed
First Posted : September 3, 2004
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Drug: penclomedine Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Oral Penclomedine
Study Start Date : October 1997
Actual Primary Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
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.
 Drug: penclomedine


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002946


Locations
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United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: George Wilding, MD University of Wisconsin, Madison
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002946    
Other Study ID Numbers: CDR0000065413
WCCC-CO-9693
NCI-T96-0067
CDR0000065413 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 3, 2004    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: January 2013
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Penclomedine
Antineoplastic Agents