Perillyl Alcohol in Treating Patients With Refractory Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: perillyl alcohol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A PHASE I STUDY OF PERILLYL ALCOHOL IN PATIENTS WITH REFRACTORY MALIGNANCIES (NSC #641066) |
| Enrollment: | 25 |
| Study Start Date: | October 1996 |
| Primary Completion Date: | April 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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 |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002862 History of Changes |
| Other Study ID Numbers: | CDR0000065133, YALE-HIC-8895, NCI-T96-0064D |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ethanol Perilla alcohol |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013