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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 December 2012 |
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Main ID: |
NCT00336063 |
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Date of registration:
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08/06/2006 |
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Primary sponsor: |
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Public title:
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Vorinostat and Azacitidine in Treating Patients With Locally Recurrent or Metastatic Nasopharyngeal Cancer or Nasal Natural Killer T-Cell Lymphoma
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Scientific title:
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A Phase I Trial of 5Azacitidine and Suberoylanilide Hydroxamic Acid in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma and Nasal NK-T Cell Lymphoma |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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18 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00336063 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Hong Kong
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Singapore
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United States
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Contacts
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Name:
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Wen-Son Hsieh |
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Address:
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Telephone:
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656-772-5371 |
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Email:
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hsiehwe@gmail.com |
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Affiliation:
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Name:
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Wen-Son Hsieh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy proven nasopharyngeal carcinoma (WHO type 3) or extranodal nasal type natural
killer (NK)/T-cell non-Hodgkin's lymphoma
- Recurrence or metastases does not require tissue documentation
- Meets 1 of the following staging criteria:
- Locally recurrent disease
- Treated with = 1 chemotherapy regimen after relapse
- Not amenable to surgical resection
- Not amenable to further curative radiotherapy
- Metastatic disease
- No clinical evidence of CNS involvement, including brain metastases or carcinomatous
meningitis
- Skull base involvement allowed
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy > 6 months
- WBC = 3,000/mm³
- Absolute neutrophil count = 1,500/mm³
- Platelet count = 100,000/mm³
- Bilirubin = 1.5 times upper limit of normal (ULN)
- AST/ALT = 2.5 times ULN (< 5 times ULN if liver metastases present)
- PTT = 1.5 times ULN
- Albumin = 2.7 g/dL
- Creatinine = 1.5 times ULN OR creatinine clearance > 50 mL/min
- No uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit study compliance
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- No history of allergic reaction to compounds of similar chemical or biologic
composition to azacitidine or vorinostat (SAHA)
- No chronic active hepatitis B
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
or radiotherapy and recovered
- At least 2 weeks since prior valproic acid
- No more than 1 concurrent multivitamin daily
- No concurrent prophylactic hematopoietic growth factors
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
- No other concurrent chemotherapy (including photopheresis), psoralen-ultraviolet
treatment (PUVA), radiotherapy, or biologic therapy
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult Nasal Type Extranodal NK/T-cell Lymphoma
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Recurrent Lymphoepithelioma of the Nasopharynx
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Recurrent Squamous Cell Carcinoma of the Nasopharynx
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Stage IV Lymphoepithelioma of the Nasopharynx
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Stage IV Squamous Cell Carcinoma of the Nasopharynx
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Intervention(s)
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Drug: azacitidine
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Drug: vorinostat
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Other: diagnostic laboratory biomarker analysis
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Other: pharmacological study
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Procedure: axillary lymph node biopsy
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Primary Outcome(s)
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MTD of SAHA in conjunction with azacitidine defined as the dose at which less than one-third of patients experience a DLT Graded according to the National Cancer Institute (NCI)/Division of Cancer Treatment (DCT) common toxicity criteria
[Time Frame: Day 28]
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Secondary Outcome(s)
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Pharmacokinetics of SAHA in patients with locally recurrent and metastatic nasopharyngeal carcinoma and NK-T cell Nasal Lymphoma
[Time Frame: Days 1 and 14 of course 1]
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Proportions of patients with high and low histone acetylation
[Time Frame: Baseline]
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Secondary ID(s)
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CDR0000472702
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CTRG NP03/19/04
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NCI-2009-00089
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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