Clinical trial · Interventional
Perillyl Alcohol in Preventing Recurrent Breast Cancer in Women Who Have Been Treated With Surgery With or Without Adjuvant Therapy
Multiple-Dose Phase I and Pharmacokinetic Trial of Perillyl Alcohol
NCT00022425CI-TRIAL-00013018unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the recurrence of cancer. The use of perillyl alcohol may be effective in preventing the recurrence of breast cancer. PURPOSE: Phase I trial to study the effectiveness of perillyl alcohol in preventing the recurrence of breast cancer in women who have been treated with surgery with or without adjuvant therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perillyl alcohol | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Personal history of stage Tis, I, II, or IIIA breast cancer * Previously treated with definitive resection with curative intent * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Over 18 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.6 mg/dL Other: * No known malabsorption syndrome * No contraindication to perillyl alcohol * No hypersensitivity to citrus or soybean products * No non-breast malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ * No active malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 months since prior chemotherapy Endocrine therapy: * Concurrent adjuvant hormonal therapy allowed Radiotherapy: * At least 6 months since prior radiotherapy Surgery: * See Disease Characteristics * At least 6 months since prior surgery * At least 2 years since prior primary surgery * More than 4 weeks since prior surgery requiring general anesthesia, including breast reconstructive surgery Other: * More than 3 months since prior enrollment in a single-dose study of perillyl alcohol * More than 3 months since prior enrollment in current study (at a lower dose level) * No concurrent vitamin supplements except a daily multivitamin (recommended daily allowance)
References
Publications (0)
Data not yet available
No reference posted for this study.