Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable Solid Tumors

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

Summary

This phase I trial is studying the side effects and best dose of vorinostat and bortezomib in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Vorinostat

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy, metastatic or unresectable disease

• Standard curative or palliative measures do not exist OR are no longer effective

• Measurable or evaluable disease

• No known brain metastases

• ECOG 0-2 OR Karnofsky 60-100%

• Life expectancy > 12 weeks

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• No history of myocardial infarction

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No severe pulmonary disease requiring oxygen

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 28 days after study participation

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or agents

• No pre-existing neuropathy ≥ grade 2

• No uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• No prior radiotherapy to > 25% of bone marrow

• At least 4 weeks since prior radiotherapy and recovered

• At least 2 weeks since prior valproic acid

• No prior bortezomib

• No concurrent enzyme-inducing anticonvulsant agents

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer therapy