Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

NCT00937495 | Completed Phase 2 Results

• 5 other identifiers: NCI-2011-03810MC0778CDR0000646715MAYO-MC0778N01CM62205
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief Summary

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and 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.

Conditions

Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Confirmed Tumor Responses

  The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.

  Up to 2 years

Secondary Outcomes (2)

• Progression Free Survival

  Up to 2 years

• Overall Survival

  Time from registration to death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment (vorinostat, bortezomib)

EXPERIMENTAL

Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: vorinostat; Drug: bortezomib

Interventions

vorinostat DRUG

400 mg given PO

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza

Treatment (vorinostat, bortezomib)

bortezomib DRUG

1.3 mg/m\^2 given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (vorinostat, bortezomib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced, unresectable, or metastatic soft tissue sarcoma (STS)
• Measurable disease, defined as \>= 1 lesion that can be accurately measured in \>= 1 dimension as \>= 2 cm by conventional techniques OR \>= 1 cm by spiral computed tomography (CT) scan
• No small round cell tumors, including the following:
• Primitive neuroectodermal tumor
• Rhabdomyosarcoma
• Ewing sarcoma
• Osteosarcoma
• No known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g., corticosteroids)
• Treated, inactive brain metastases not requiring ongoing therapy allowed provided the brain metastases have been stable for \>= 1 month as assessed by intracranial imaging AND there is no indication of increased vascularity of the treated metastases within 14 days before study entry as assessed by magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy \>= 12 weeks
• Absolute neutrophil count (ANC) \>= 1,500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Total bilirubin normal
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 2.5 times upper limit of normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (6)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Metro-Minnesota CCOP

Saint Louis Park, Minnesota, 55416, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Vorinostat; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Steven Attia, D.O.
• Organization: University of Wisconsin

sa2@medicine.wisc.edu

Study Officials

• Steven Attia

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: June 1, 2011
• Last Updated: May 14, 2014
• Results First Posted: November 21, 2013

Record last verified: 2013-09

Locations

US (6)