Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02369458|
Recruitment Status : Recruiting
First Posted : February 24, 2015
Last Update Posted : October 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck Squamous Cell Carcinoma, Head and Neck||Drug: Mitomycin-C Drug: Pegfilgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies|
|Actual Study Start Date :||April 14, 2015|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Arm 1: p16+ OPSCC
Experimental: Arm 2: p16- HNSCC
- Tumor response rate (TRR) [ Time Frame: Approximately 6 months (due to estimated median PFS of 6 months) ]
TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase.
RECIST 1.1 will be used for this outcome.
- Tumor response rate (TRR) for participants enrolled post October 2020 [ Time Frame: Approximately 6 months (due to estimated median PFS of 6 months) ]
TRR will be evaluated in p16+ (HPV positive) OPSCC HNSCC patients
RECIST 1.1 will be used for this outcome.
- Progression-free survival (PFS) [ Time Frame: Approximately 6 months (due to estimated median PFS of 5.6 months) ]
PFS is defined as the duration of time from start of treatment to time of first radiologic confirmation of progression or death, whichever occurs first.
Progressive disease per RECIST 1.1
- Target lesions - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
- Non-target lesions:Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
- Grades 3 and 4 adverse events [ Time Frame: 28 days after completion of treatment (estimated treatment completion of 6 months) ]Using CTCAE Version 3.0
- Overall survival (OS) [ Time Frame: Approximately 11 months (due to estimated OS of 10.1 months) ]
- Quality of life [ Time Frame: Baseline, every 5 weeks, and end of treatment (estimated at 6 months) ]
Assessment tools include:
- EORTC QLQ-C30: this has a total score, one general QOL, and one "within the last week" subscale, as well as a general health item and a single overall QOL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much.
- Cognitive Failures Questions (CFQ) - has 3 subscales describing perception, memory, and motor function. A change in 1 standard deviation will be considered a perceptible difference. The participants can choose a scale from 0-4 with 0 being Never and 4 being Very Often.
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): NCT02369458
|Contact: Peter Oppelt, M.D.||email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Peter Oppelt, M.D. 636-916-9922 firstname.lastname@example.org|
|Principal Investigator: Peter Oppelt, M.D.|
|Sub-Investigator: Kevin Palka, M.D.|
|Sub-Investigator: Douglas Adkins, M.D.|
|Principal Investigator:||Peter Oppelt, M.D.||Washington University School of Medicine|