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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

John R. Murren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065133

NCT ID:

NCT00002862

Start Date:

October 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • 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 IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/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 IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028