Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Түлхүүр үгс
Хураангуй
Тодорхойлолт
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.
- Determine the safety and tolerability of this drug in these participants.
- Determine the pharmacokinetics of this drug in these participants.
Secondary
- Determine the effects of this drug on selected markers of sexual function in these participants.
- Determine the effects of this drug on markers of susceptibility to cancer in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study. Participants at each dose level are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.
- Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3 participants receive escalating doses of indole-3-carbinol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 participants experiences dose-limiting toxicity. An additional cohort of 3 participants is treated at the MTD.
Participants are followed on days 2, 3, and 6.
PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued for this study.
Огноо
| Сүүлд баталгаажуулсан: | 04/30/2006 |
| Эхлээд оруулсан: | 01/06/2005 |
| Тооцоолсон элсэлтийг оруулсан: | 01/06/2005 |
| Эхлээд нийтэлсэн: | 01/09/2005 |
| Сүүлийн шинэчлэлтийг оруулсан: | 07/22/2008 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 07/23/2008 |
| Сургалтын бодит эхлэх огноо: | 10/31/2004 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: indole-3-carbinol
Үе шат
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | DISEASE CHARACTERISTICS: - Healthy participants - Non-smoker - No drug abuse, as determined by urine cotinine and baseline drug screen PATIENT CHARACTERISTICS: Age - 18 to 70 Performance status - Not specified Life expectancy - At least 12 months Hematopoietic - Absolute granulocyte count > 1,500/mm^3 - Hemoglobin > 10 g/dL Hepatic - Bilirubin < 1.8 mg/dL - AST and ALT < 110 U/L - Alkaline phosphatase < 300 U/L Renal - Creatinine < 2.0 mg/dL - Albumin > 3.0 g/dL Pulmonary - No asthma Other - Not pregnant or nursing - Negative pregnancy test - Weight within 20% of ideal body weight by the Metropolitan Life table - No serious drug allergies - No arthritis - No acute, unstable, chronic, or recurring medical condition - No strict vegetarians - No diabetes - No evidence of an active malignancy - No other serious intolerance or allergies - Mild seasonal allergies allowed - No other serious acute or chronic illness - None of the following chronic conditions: - Headaches - Dysphoria - Fatigue - Dizziness - Blurred vision - Insomnia - Rhinorrhea - Nausea - Vomiting - Abdominal pain - Diarrhea - Constipation - Premenstrual syndrome - Cessation of menses within the past 10 days (menstruating women only) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Concurrent oral contraceptives allowed Radiotherapy - Not specified Surgery - Not specified Other - More than 21 days since prior medications, herbal products, dietary supplements, or high-dose vitamins - More than 3 months since prior investigational drugs - At least 14 days since prior and no concurrent ingestion of cruciferous vegetables, including any of the following: - Broccoli - Cabbage, including coleslaw - Cauliflower - Bok-choy - Brussels sprouts - Collards - Kale - Kohlrabi - Mustard greens - Rutabaga - Turnip - Watercress - At least 7 days since prior and no concurrent alcohol consumption - At least 48 hours since prior ingestion of grapefruit-containing foods and beverages - No concurrent chronic drug therapy - No other concurrent supplements, including dietary supplements, vitamins, herbal products, or over-the-counter medications |
