Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

May 14, 2020 updated by: Johns Hopkins University

A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.

Study Overview

Status

Withdrawn

Conditions

Nasopharyngeal Carcinoma

Intervention / Treatment

Drug: Velcade

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Hong Kong, China
    - Chinese University of Hong Kong
Singapore
- - Singapore, Singapore
    - Johns Hopkin Singapore International Medical Center
  - Singapore, Singapore
    - National University Hospital of Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
metastatic disease or locally recurrent disease not amendable curative therapy
Patients must have measurable disease
least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
An ECOG performance status of 0-2
Absolute neutrophil count (ANC) ≥1500/mm3
Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).
PLT ≥ 75,000/mm 3
Total bilirubin ≤ 2 x upper normal limit (UNL)
Serum ALT ≤ 5 x UNL
Serum creatinine ≤ 2 mg/dL
Serum albumin ≥ 2.5 g/dL
No known history of brain or leptomeningeal metastasis.
≥ 18 years of age.
Estimated life expectancy ≥ 24 weeks.
For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.
must be able to give informed written consent

Exclusion Criteria:

Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
Prior BORTEZOMIB therapy
Immunotherapy ≤ 4 weeks have elapsed prior to study entry
Biologic therapy ≤ 4 weeks have elapsed prior to study entry
Radiation therapy ≤ 4 weeks have elapsed prior to study entry
Major surgery, or significant traumatic injury ≤3 weeks prior to study entry
Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
Evidence of CNS involvement
Presence of > grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.
Patients with significant local symptoms from metastases which is amenable to radiotherapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.
History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.
Uncontrolled intercurrent illness
Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
Known history of HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy based on response of measurable disease Time Frame: duration of study (4 -6 months)	duration of study (4 -6 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
EBV viral load Time Frame: duration of study (4 -6 months)	duration of study (4 -6 months)
toxicities Time Frame: duration of study (4 -6 months)	duration of study (4 -6 months)
molecular characterization of EBV in Plasma Time Frame: duration of study (4 -6 months)	duration of study (4 -6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Janssen-Cilag Ltd.

Investigators

Study Chair: Wen-son Hsieh, M.D., Johns Hopkins Singapore-International Medical Center
Study Chair: Brigette Ma, M.D., Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria