Vorinostat and Alvocidib in Treating Patients With Advanced 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 when given together with alvocidib in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as vorinostat and alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with alvocidib may kill more tumor cells.

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor

• Metastatic or unresectable disease

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

• No hematologic malignancies

• No known brain metastases

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• WBC ≥ 3,000/mm^3

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

• Platelet count ≥ 100,000/mm^3

• Bilirubin ≤ 1.5 mg/dL

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal OR creatinine clearance ≥ 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs

• No uncontrolled intercurrent illness, including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situations that would preclude study compliance

• Recovered from prior therapy

• At least 2 weeks since prior histone acetylase inhibitors, including valproic acid

• At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• At least 2 weeks since prior investigational therapy

• At least 2 weeks since prior radiotherapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent commonly used vitamins, antioxidants, or herbal preparations and supplements

• A single tablet multivitamin is allowed

• No other concurrent anticancer agents or therapies for this mailgnancy

• No other concurrent investigational agents