Study of Curcumin, Vorinostat, and Sorafenib

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn the highest tolerable dose of the combination of curcumin, vorinostat, and sorafenib that can be given to patients with advanced solid cancer. The safety of this drug combination will also be studied.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Sabinsa Corporation
• Treatments: Curcumin; Niacinamide; Sorafenib; Vorinostat

Criteria

Inclusion Criteria:

1. Patients must have an advanced solid tumor that has either failed one or more prior therapies or where there is no established standard of care therapy.

2. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 2 or better (0-2).

3. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count (ANC) > 1,500/uL; Platelets > 100,000/uL; Total bilirubin within normal limits (patients with Gilbert's syndrome must have total bilirubin < 3.0 mg/dL) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (ULN); Creatinine/= 9.0 gm/dL; prothrombin time (PT)/ partial thromboplastin time (PTT) within normal limits

4. Patients must be able to understand and be willing to sign an IRB-approved written informed consent document.

5. Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g. barrier method) prior to study entry, for the duration of study participation, and for 30 days after the last dose.

6. Patients must be 18 years of age or older since the safety and dosages of these study drugs has not been demonstrated in the pediatric population. However, patients who are 13 years old or older and have more than 50 kg of body weight will be eligible after consultation with their pediatric attending.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.

2. Inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications), any prior history of hypertensive crisis or hypertensive encephalopathy, and history of myocardial infarction or unstable angina within 6 months prior to study enrollment.

3. History of stroke or transient ischemic attack within 6 months prior to study enrollment and significant vascular disease (e.g., aortic aneurysm, aortic dissection) and symptomatic peripheral vascular disease.

4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study. Minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.

5. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or GI bleeding within 6 months prior to study enrollment; or serious, non-healing wound, ulcer, or bone fracture. Patients who have had a history of acute diverticulitis, GI obstruction, abdominal carcinomatosis, or peptic ulcer disease (known risks for bowel perforation) confirmed by endoscopy within the past 6 months, will also be excluded.

6. Patients on therapeutic warfarin with history of deep vein thrombosis and/or pulmonary embolism.

7. History of allergic reactions to the study drugs or their analogs.

8. Patients that have had any treatment specific for tumor control within 3 weeks of study drug treatment or: a. within 2 weeks if cytotoxic agents were given weekly b. within 6 weeks for nitrosoureas or mitomycin C c. within 4 half-lives for targeted agents with half lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents) d. failed to recover from toxic effects of any therapy prior to study entry

9. Urine for proteinuria >/= 2+ (patients discovered to have >/= 2+ proteinuria on urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate

10. Patients with insulin dependent diabetes or poorly controlled type 2 diabetes.

11. Inability to swallow oral medication.

12. Pregnant or breastfeeding women.

13. Concurrent enrollment on another research study.