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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Velcade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Velcade|velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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