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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Janssen-Cilag Ltd.
• Treatments: Bortezomib

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