Perillyl Alcohol in Treating Patients With Refractory Cancer

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002862
• Other study ID #: CDR0000065133
• Secondary ID: YALE-HIC-8895NCI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 8, 2013
• Start date: October 1996

Study information

• Verified date: September 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• perillyl alcohol

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,