Phenylbutyrate in Treating Patients With Refractory Solid... | NCT00002909 | Trialant
NCT00002909
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Feb 5, 2013Estimated
Enrollment
24Actual
Phase
Phase 1
Conditions
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
chemotherapy
oral sodium phenylbutyrate
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
NCT00002909
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NCI-2012-02250
Secondary IDs
ID
Type
Description
Link
J-9616
JHOC-9616
NCI-T95-0017H
CDR0000065274
Registry Identifier
PDQ (Physician Data Query)
Brief Title
Phenylbutyrate in Treating Patients With Refractory Solid Tumors or Lymphoma
Official Title
A PHASE I CLINICAL AND PHARMACOLOGIC EVALUATION OF PHENYLBUTYRATE IN PATIENTS WITH REFRACTORY SOLID TUMORS: STUDY OF CONTINUOUS EXPOSURE ORAL PHENYLBUTYRATE ON A THREE TIMES DAILY SCHEDULE
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Feb 2001
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
Feb 1997
Primary Completion Date
Oct 2000Actual
Completion Date
Not provided
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Aug 10, 2004
First Posted Date
Aug 11, 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 4, 2013
Last Update Posted Date
Feb 5, 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 effectivenes of phenylbutyrate in treating adults with refractory solid tumor or lymphoma. 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 of oral phenylbutyrate that can be given three times daily in patients with refractory solid tumors or lymphoma until disease progression or a trough plasma concentration of 2-6 micromoles per liter is achieved.
II. Characterize the pharmacokinetics of oral phenylbutyrate absorption, and determine whether there is time dependence in the systemic clearance rate during multiple dosing.
III. Seek preliminary evidence of therapeutic activity of phenylbutyrate when administered on this schedule in these patients.
IV. Correlate any observed responses and toxic effects with results of bioassays and tissue sampling for phenylbutyrate activity.
OUTLINE: This is a dose-seeking study.
All patients receive oral phenylbutyrate three times daily. Groups of 4 or more patients receive escalating doses of phenylbutyrate until the maximum tolerated dose (MTD) is determined. Treatment continues until disease progression or unacceptable toxicity intervenes.
Conditions Module
Conditions
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
unspecified adult solid tumor, protocol specific
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
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
24Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm I
Experimental
All patients receive oral phenylbutyrate three times daily. Groups of 4 or more patients receive escalating doses of phenylbutyrate until the maximum tolerated dose (MTD) is determined. Treatment continues until disease progression or unacceptable toxicity intervenes.
Drug: chemotherapy
Drug: oral sodium phenylbutyrate
Interventions
Name
Type
Description
Arm Group Labels
Other Names
chemotherapy
Drug
Arm I
oral sodium phenylbutyrate
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma that is progressive or refractory to conventional therapy or for which no effective therapy is known
Priority given to hormone-refractory prostate cancer and melanoma
No untreated CNS metastases
Head CT not required in the absence of clinical signs or symptoms but recommended for metastatic melanoma
PATIENT CHARACTERISTICS:
Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: At least 3 months
WBC greater than 2,000/mm3 OR absolute neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3
Hemoglobin greater than 9 g/dL
Bilirubin less than 1.5 mg/dL
AST/ALT less than 1.5 times normal
Creatinine less than 2.0 mg/dL
Obstructive uropathy allowed if relieved by nephrostomy or other appropriate device
Left ventricular ejection fraction greater than 40% by MUGA or normal by echocardiogram
No history of congestive heart failure
No uncontrolled hypertension (diastolic greater than 110 mm Hg)
Forced expiratory volume (1 second) greater than 1.5 L/min
No active infection, including HIV or viral hepatitis
No active seizure disorder
No clinical evidence of increased intracranial pressure
No baseline dementia (mini-mental exam less than 23)
No autoimmune disease, including systemic lupus erythematosus, scleroderma, or other connective tissue illness
No nonmalignant medical or psychiatric problem of sufficient severity to limit full compliance with study or to pose undue risk
Not pregnant or nursing
Adequate contraception required of fertile patients for 2 weeks prior to, during, and for 3 months after study
Normal gastrointestinal function with ability to tolerate large intake of oral volume required for phenylbutyrate administration
Patients with persistent nausea or moderate to severe anorexia may not be good candidates for study
PRIOR CONCURRENT THERAPY:
Fully recovered from all prior therapy
Prior suramin allowed if serum suramin level less than 50 micrograms/mL at entry
At least 28 days since chemotherapy
No prior phenylacetate, phenylbutyrate, or antineoplaston therapy
The following may be continued during study:
Luteinizing hormone-releasing hormone agonist with evidence of tumor progression (e.g., rising prostate-specific antigen, new lesions on bone scan) despite therapy
Adrenal steroid replacement (if needed)
Dexamethasone or other steroids
At least 4-6 weeks since flutamide with evidence of PSA progression required (if possible)
At least 28 days since radiotherapy
At least 28 days since major surgery
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
Michael A. Carducci, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Johns Hopkins Oncology Center
Baltimore
Maryland
21287
United States
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Carducci M, Bowling MK, Eisenberger M, et al.: Phenylbytyrate (PB) for refractory solid tumors: Phase I evaluation of continuous oral PB exposure. [Abstract] Proc Am Assoc Cancer Res 39: A507, 1998.
See Also Links
Not provided
Available IPD Information
Not provided
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
D004358
Drug Therapy
C075773
4-phenylbutyric acid
Ancestor Terms
ID
Term
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
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 III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue