Completed

A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES (NSC #641066)

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What is being tested

perillyl alcohol

Drug
Who is being recruted

Lymphadenopathy+35

+ Chronic Disease

+ DNA Virus Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 1996
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1996

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Estimate the maximum tolerated dose of perillyl alcohol given chronically three times per day in patients with refractory malignancies. II. Describe the toxic effects and pharmacokinetics associated with this regimen. III. Evaluate any antitumor activity of perillyl alcohol in these patients. IV. Assess the ability of perillyl alcohol to induce tumor differentiation and reduce telomerase activity in patients from whom serial biopsies can be obtained. OUTLINE: This is a dose escalation study to determine the maximum tolerated dose of perillyl alcohol. 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. Patients are followed for duration of response and survival.

NCT00002862
Principal SponsorNational Cancer Institute (NCI)
Last updated: February 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellEpstein-Barr Virus InfectionsDisease AttributesBurkitt LymphomaHodgkin DiseaseImmunoblastic LymphadenopathyLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Yale Comprehensive Cancer Center

New Haven, United StatesOpen Yale Comprehensive Cancer Center in Google Maps
CompletedOne Study Center