Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of Head and Neck
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|ClinicalTrials.gov Identifier: NCT01275183|
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: raltegravir and cisplatin||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|Experimental: Raltegravir and cisplatin||
Drug: raltegravir and cisplatin
Cisplatin, intravenous, 30 mg/m2, days 2 and 16, 1 to 2 hours
Raltegravir, oral,400 mg, twice per day, days 1 through 5 or days 15 to 19
Part 2 (optional): Docetaxel, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles
Part 2 (optional): Cisplatin, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles
Part 2: (optional): Raltegavir, oral, 400 mg, twice per day, days 1 through 5, 3 to 6 cycles
- Gene expression modification [ Time Frame: 3 weeks ]Expression changes of three selected tumor biomarkers (DNA damage and apoptosis) will be measured at baseline, after cisplatin alone, and after raltegravir-cisplatin. Tumor biomarkers include pChk2, Annexin V, and metnase.
- Clinical activity [ Time Frame: 2 to 6 months ]
Preliminary clinical activity of the combination of raltegravir and cisplatin-based chemotherapy in HNSCC will be measured by RECIST criteria. Patients who elect participation in Part 2 will undergo tumor response assessment in accordance with RECIST 1.1 criteria after every 3 cycles of cisplatin-docetaxel-raltegravir. Response rate after 3 cycles will be reported as applicable.
Preliminary toxicity of the combination of raltegravir and cisplatin-based chemotherapy in HNSCC as measured by the grading system (0-4) of the NCI CTCAE v.4
Baseline Metnase expression in HNSCC.
- Clinical toxicity [ Time Frame: 2 to 6 months ]Preliminary toxicity of the combination of raltegravir and cisplatin-based chemotherapy in HNSCC as measured by the grading system (0-4) of the NCI CTCAE v.4
- Progression free survival and overall survival [ Time Frame: 2 years ]Progression-free and overall survival duration will be measured from entry into the protocol, until death.
- Metnase expression [ Time Frame: 2 to 6 months ]From biopsy materials, quantitative score generated by Aperio Scanning. Digital photomicrographs will be scored for frequency and intensity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275183
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Houman Fekrazad, MD||University of New Mexico Cancer Center|