Penclomedine in Treating Patients With Solid Tumors or Ly... | NCT00002946 | Trialant
NCT00002946
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Feb 11, 2013Estimated
Enrollment
30Actual
Phase
Phase 1
Conditions
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
penclomedine
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00002946
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000065413
Secondary IDs
ID
Type
Description
Link
WCCC-CO-9693
NCI-T96-0067
CDR0000065413
Registry Identifier
PDQ (Physician Data Query)
Brief Title
Penclomedine in Treating Patients With Solid Tumors or Lymphoma
Official Title
A Phase I Trial of Oral Penclomedine
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 1997
Primary Completion Date
Apr 2002Actual
Completion Date
Not provided
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Sep 2, 2004
First Posted Date
Sep 3, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 8, 2013
Last Update Posted Date
Feb 11, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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.
Conditions Module
Conditions
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
30Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
penclomedine
Drug
Arm I
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
George Wilding, MD
University of Wisconsin, Madison
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Wisconsin Comprehensive Cancer Center
Madison
Wisconsin
53792
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D006689
Hodgkin Disease
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D002051
Burkitt Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D020522
Lymphoma, Mantle-Cell
D007119
Immunoblastic Lymphadenopathy
D017728
Lymphoma, Large-Cell, Anaplastic
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C058388
penclomedine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
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
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
stage I mantle cell lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage I marginal zone lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
contiguous stage II marginal zone lymphoma
contiguous stage II small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue