NCT00002909

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2000

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2001

Enrollment Period

3.7 years

First QC Date

November 1, 1999

Last Update Submit

February 4, 2013

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomaunspecified adult solid tumor, protocol specificstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (1)

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: chemotherapyDrug: oral sodium phenylbutyrate

Interventions

chemotherapyDRUG
Arm I
oral sodium phenylbutyrateDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Drug Therapy4-phenylbutyric acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphadenopathyLymphoma, T-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Michael A. Carducci, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

February 1, 1997

Primary Completion

October 1, 2000

Last Updated

February 5, 2013

Record last verified: 2001-02

Locations

US(1)