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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Velcade
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese University of Hong Kong
  • Johns Hopkin Singapore International Medical Center
  • National University Hospital of Singapore

Outcomes

Primary Outcome Measures

Efficacy based on response of measurable disease

Secondary Outcome Measures

EBV viral load
toxicities
molecular characterization of EBV in Plasma

Full Information

First Posted
August 21, 2006
Last Updated
May 14, 2020
Sponsor
Johns Hopkins University
Collaborators
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00367718
Brief Title
Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Official Title
A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI left JHU and is not able to be reached for updates
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Janssen-Cilag Ltd.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Velcade
Intervention Description
velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.
Primary Outcome Measure Information:
Title
Efficacy based on response of measurable disease
Time Frame
duration of study (4 -6 months)
Secondary Outcome Measure Information:
Title
EBV viral load
Time Frame
duration of study (4 -6 months)
Title
toxicities
Time Frame
duration of study (4 -6 months)
Title
molecular characterization of EBV in Plasma
Time Frame
duration of study (4 -6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-son Hsieh, M.D.
Organizational Affiliation
Johns Hopkins Singapore-International Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Brigette Ma, M.D.
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
China
Facility Name
Johns Hopkin Singapore International Medical Center
City
Singapore
Country
Singapore
Facility Name
National University Hospital of Singapore
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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