Trial Outcomes & Findings for Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer (NCT NCT01581970)
NCT ID: NCT01581970
Last Updated: 2019-09-11
Results Overview
The number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions.
COMPLETED
PHASE2
7 participants
At 2 Years
2019-09-11
Participant Flow
Participant milestones
| Measure |
Cetuximab/Low Dose Cyclophosphamide
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=7 Participants
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At 2 YearsThe number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions.
Outcome measures
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=7 Participants
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Progression
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 Weeks Post Treatment with CyclophosphamideThe ratio of Tregs to effector cells (NK cells, CD 8+ lymphocytes, macrophages/monocytes) in tumor tissue as measured by immune-histochemistry (IHC) of tumor tissue for all Participants. Measure of central tendency was collected but the data is not accessible anymore because PI left institution and did not respond to requests for data.
Outcome measures
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=4 Participants
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Aggregate Ratio of Tregs to Effector Cells for All Participants
|
0.112 ratio
|
SECONDARY outcome
Timeframe: 6 Weeks Post Treatment with CyclophosphamidePopulation: Measure of central tendency could not be used as the data was not originally reported in this manner and is not accessible anymore because the PI left institution and did not respond to requests for data.
the Ratio of Tregs to NK cells in peripheral blood as measured by flow cytometry for all Participants. Measure of central tendency was collected but the data is not accessible anymore because the PI left institution and did not respond to requests for data.
Outcome measures
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=4 Participants
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Aggregate Ratio of Tregs to Natural Killer (NK) Cells for All Participants
|
2.443 ratio
|
SECONDARY outcome
Timeframe: Week 6Population: This outcome measure was considered to not be helpful and the data was not collected.
Myeloid-derived suppressor cells in tumor tissue as measured by immune-histochemistry (IHC)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Comparison from Baseline to Week 6 and Week 12Population: At this point, the data is not able to be analyzed because the PI left the institution and did not respond to requests for data.
Comparison of health related quality of life scores as measured by FACT-G: Functional Assessment of Cancer Therapy - General (constitutes the core of all subscales; the FACT-G can be used with patients of any tumor type)questionnaire. At this point, the data is not able to be analyzed because the PI left the institution and did not respond to requests for data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsDefined as the number of patients alive two years out from study enrollment.
Outcome measures
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=7 Participants
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Overall Survival
|
1 Participants
|
Adverse Events
Cetuximab/Low Dose Cyclophosphamide
Serious adverse events
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=7 participants at risk
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Nervous system disorders
Seizure
|
14.3%
1/7
|
Other adverse events
| Measure |
Cetuximab/Low Dose Cyclophosphamide
n=7 participants at risk
Safety population as defined by all patients receiving at least one treatment with cyclophosphamide on Day 1.
Cyclophosphamide: Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
Cetuximab: The initial dose of cetuximab 400 mg/m\^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m\^2 intravenously (IV) over 60 minutes.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7
|
|
General disorders
Chills
|
14.3%
1/7
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
28.6%
2/7
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
14.3%
1/7
|
|
General disorders
Fatigue
|
28.6%
2/7
|
|
General disorders
Fever
|
28.6%
2/7
|
|
Gastrointestinal disorders
Odynophagia
|
14.3%
1/7
|
|
Nervous system disorders
Headache
|
28.6%
2/7
|
|
Injury, poisoning and procedural complications
Intestinal Stoma Leak
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7
|
|
Gastrointestinal disorders
Oral Pain
|
14.3%
1/7
|
|
General disorders
Neck Mass Pain
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Extremity Pain
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Rash, Papulopustular
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Rash, Maculopapular
|
71.4%
5/7
|
|
Skin and subcutaneous tissue disorders
Rash, Acneiform
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
14.3%
1/7
|
|
Infections and infestations
Skin Infection
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
14.3%
1/7
|
|
Vascular disorders
Thromboembolic Event
|
14.3%
1/7
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Wound Complication
|
14.3%
1/7
|
Additional Information
Dr. Gautam Jha
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place