Breast CancerPhase 2NCT00003219
Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer
A Phase 2 study testing perillyl alcohol in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- perillyl alcohol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1998to May 1998
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Microscopically confirmed metastatic breast cancer Must be refractory or have recurred after at least 1 systemic chemotherapy regimen Estrogen receptor positive tumors must have failed or recurred after hormonal therapy At least 1 site of measurable disease required Previously radiated lesions are not considered measurable unless there is evidence of disease progression after completion of radiation therapy No known brain metastases Hormone receptor status: Unspecified
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL BUN no greater than 30 mg/dL Other: Effective birth control must be used by fertile patients (barrier method preferred) Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Recovered from toxic effects of prior treatment Biologic therapy: No immunologic therapy within the past 2 weeks Chemotherapy: No chemotherapy within the past 4 weeks (6 weeks for mitomycin or nitrosoureas) See Disease Characteristics Endocrine therapy: No hormonal therapy within the past 2 weeks See Disease Characteristics Radiotherapy: No radiotherapy within the past 4 weeks See Disease Characteristics Surgery: Not specified Other: No concurrent cholesterol lowering agents, supplemental vitamins, or other antioxidants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy.
Read the detailed description
OBJECTIVES: I. Determine the clinical effectiveness (i.e., objective tumor response, time to treatment failure, and survival) of perillyl alcohol in patients with previously treated metastatic breast cancer. II. Define the acute and chronic toxic effects of perillyl alcohol in this patient population.
OUTLINE: Patients are given oral perillyl alcohol 4 times per day. Dose escalation of perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed. Treatment is continued as long as the patient benefits from treatment, does not show progressive disease, and does not experience irreversible or life threatening toxicity. Patients are evaluated for response monthly while receiving treatment on this study. Patients are followed at 2-4 weeks after the last treatment.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued over 2 years.
- Conditions
- Breast Cancer
- Being tested
- perillyl alcohol
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perillyl alcoholDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2004 (estimated)
- Study startMay 1998
- Primary completionMay 1998
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Howard H. Bailey, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003219
- Sponsor's protocol ID
- CDR0000066080
- Other IDs
- R21CA072500, WCCC-CO-9611, NCI-T97-0068
- Status last verified
- Oct 2012
- First submitted
- 1 Nov 1999
- Last updated
- 13 Dec 2019
- Results posted
- No
Publications
Bailey HH, Attia S, Love RR, Fass T, Chappell R, Tutsch K, Harris L, Jumonville A, Hansen R, Shapiro GR, Stewart JA. Phase II trial of daily oral perillyl alcohol (NSC 641066) in treatment-refractory metastatic breast cancer. Cancer Chemother Pharmacol. 2008 Jun;62(1):149-57. doi: 10.1007/s00280-007-0585-6. Epub 2007 Sep 21.
PubMed 17885756
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Perillyl Alcohol (NSC 641066) Administered Daily in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003219
- Acronym / sponsor ID
- CDR0000066080
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- May 1998 (actual)
- Study completion
- May 1998 (actual)
- First posted
- 19 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients with metastatic breast cancer that has not responded to previous chemotherapy.
Detailed description
OBJECTIVES: I. Determine the clinical effectiveness (i.e., objective tumor response, time to treatment failure, and survival) of perillyl alcohol in patients with previously treated metastatic breast cancer. II. Define the acute and chronic toxic effects of perillyl alcohol in this patient population.
OUTLINE: Patients are given oral perillyl alcohol 4 times per day. Dose escalation of perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed. Treatment is continued as long as the patient benefits from treatment, does not show progressive disease, and does not experience irreversible or life threatening toxicity. Patients are evaluated for response monthly while receiving treatment on this study. Patients are followed at 2-4 weeks after the last treatment.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued over 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perillyl alcohol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Results publication: PubMed 17885756Bailey HH, Attia S, Love RR, Fass T, Chappell R, Tutsch K, Harris L, Jumonville A, Hansen R, Shapiro GR, Stewart JA. Phase II trial of daily oral perillyl alcohol (NSC 641066) in treatment-refractory metastatic breast cancer. Cancer Chemother Pharmacol. 2008 Jun;62(1):149-57. doi: 10.1007/s00280-007-0585-6. Epub 2007 Sep 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard H. Bailey, MD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perillyl alcohol in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.