NCT00002862

Brief Summary

Phase I trial to study the effectiveness of perillyl alcohol in treating patients with refractory cancer. 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
25

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

February 11, 2013

Status Verified

September 1, 2000

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

February 8, 2013

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomaunspecified adult solid tumor, protocol specificstage 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 IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic 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

Groups of 3-6 patients receive escalating doses of oral perillyl alcohol three times per day until the maximum tolerated dose or recommended phase II dose is determined. Treatment at the assigned dose continues until disease progression or unacceptable toxicity intervenes. Patients with stable disease after 8 weeks of treatment are removed from study.

Drug: perillyl alcohol

Interventions

perillyl alcoholDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed solid malignancy or lymphoma for which no effective therapy exists * Measurable or evaluable disease * No CNS metastasis unless stable for at least 4 weeks following surgery and/or radiotherapy and no requirement for anticonvulsants PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Life expectancy: At least 3 months * ANC at least 1,500 * Platelets at least 100,000 * Bilirubin no greater than 2.0 mg/dL * AST less than 2.5 times normal * Creatinine clearance at least 50 mL/min * No concurrent cholesterol-lowering agents * No active infection (including HIV) * No concomitant medical condition that precludes study compliance * No pregnant or nursing women * Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: * At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) * At least 4 weeks since wide-field radiotherapy * Fully recovered from prior 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)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

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

perillyl alcohol

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

Study Officials

  • John R. Murren, MD

    Yale University

    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

July 19, 2004

Study Start

October 1, 1996

Primary Completion

April 1, 2001

Last Updated

February 11, 2013

Record last verified: 2000-09

Locations

US(1)