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| ID | Type | Description | Link |
|---|---|---|---|
| 11-C-0129 |
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Slow, insufficient accrual and failure to meet endpoints.
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Background:
- Radiation and chemotherapy treatments for anal cancer can cause irritation of the skin that can lead to redness and tenderness, and in some cases can be so severe that it results in blistering or peeling of the skin during treatment. These conditions cause discomfort and may require breaks from radiation treatment. Researchers are interested in determining whether MTS-01, a drug that protects cells and tissues from the effects of radiation, can be given before radiation treatment to prevent these side effects and reduce the irritation of the skin during chemotherapy and radiation for anal cancer.
Objectives:
- To determine the safety and effectiveness of topical MTS-01 given before radiation in the groin and gluteal cleft of patients receiving combined radiation and chemotherapy for anal cancer.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with cancer of the anal canal and are eligible to receive radiation and chemotherapy treatments.
Design:
Background:
Objectives:
Primary Objective: To determine the safety and tolerability of topical MTS-01 on a daily basis prior to irradiation in the groin and gluteal cleft of patients receiving combined therapy with MMC, 5-FU, and RT for carcinoma of the anal canal.
Secondary Objectives will include evaluation of the following endpoints in a preliminary fashion:
Eligibility:
Design:
This is a pilot trial of topical MTS-01 in patients receiving MMC, 5-FU, and intensity-modulated radiation therapy (IMRT) for definitive management of carcinoma of the anal canal. Fifteen patients will be enrolled. MMC will be delivered at a dose of 10mg/m(2) on days 1 and 29. 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics. Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT. Radiation Therapy Oncology Group (RTOG) grading will be used to evaluate skin toxicity in both the groin and gluteal cleft weekly during treatment and at 4 weeks, 3 months and 6 months after completion of treatment. The duration of treatment, number of treatment breaks, opiate requirements, and level of pain will be evaluated weekly during treatment and at 4 weeks and 3 months after the completion of treatment. Disease control will be assessed at 4 weeks, 3 months, 6 months, 9 months, and 12 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/Chemo + Radiation | Experimental | Chemo + Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tempol | Drug | Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death related to adverse event. | Date treatment consent signed to date off study, approximately, 36 months and 10 days. |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | Date treatment consent signed to date off study, approximately, 36 months and 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | RTOG grade 1-5 were used to assess skin toxicity in the groin (right and left inguinal area) and gluteal cleft, as well as two control sites. Grade 0 is no skin toxicity, Grade 1 is follicular, faint or dull erythema, Grade 3 is tender or bright erythema, Grade 3 is confluent, moist desquamation, Grade 4 is ulceration, hemorrhage, or necrosis, and Grade 5 is death due to radiation toxicity. |
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INCLUSION CRITERIA:
Histologically proven, invasive primary squamous, basaloid, or cloacogenic carcinoma of the anal canal, stage T1-4, N0-3
No previous therapy for anal cancer.
Age greater than or equal to 18 years
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Adequate bone marrow, renal, and hepatic function defined as
Patients of childbearing potential must be willing to use a medically effective means of birth control for the duration of treatment and six weeks after treatment.
Patients must be willing and able to provide informed consent
EXCLUSION CRITERIA:
Contraindications to radiotherapy such as a history of prior radiotherapy to the pelvis or a history of inflammatory bowel disease
Prior malignancy except:
Presence of metastatic disease (M1)
Co-morbidity that in the estimation of the principal investigator would make the patient unable to tolerate treatment
Pregnant or lactating females
Human immunodeficiency virus (HIV) positive patients with cluster of differentiation 4 (CD4) < 100 cells/mL AND ECOG performance status (PS) greater than 2.
Dermatitis in the anticipated radiation treatment portal.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah E Citrin, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19474385 | Background | Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27. | |
| 15577408 | Background | Bower M, Powles T, Newsom-Davis T, Thirlwell C, Stebbing J, Mandalia S, Nelson M, Gazzard B. HIV-associated anal cancer: has highly active antiretroviral therapy reduced the incidence or improved the outcome? J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1563-5. doi: 10.1097/00126334-200412150-00004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1/Chemo + Radiation | Chemo + Radiation Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT). 5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29 Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Some baseline data was captured for 1/6 participants that later withdrew before treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1/Chemo + Radiation | Chemo + Radiation Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT). 5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29 Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Grade 1 and Higher Adverse Events Possibly, Probably, or Definitely Related to Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death related to adverse event. | 1/6 participants enrolled withdrew before treatment. | Posted | Number | Adverse events | Date treatment consent signed to date off study, approximately, 36 months and 10 days. |
|
Date treatment consent signed to date off study, approximately, 36 months and 10 days.
1/6 participants enrolled withdrew before treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1/Chemo + Radiation | Chemo + Radiation Tempol: Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of radiation therapy (RT). 5-Fluorouracil: 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. Mitomycin-C: Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29 Radiation Therapy: Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah E. Citrin | National Cancer Institute | 301-496-5457 | citrind@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2014 | Jul 26, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2014 | Jul 26, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| C001803 | tempol |
| D005472 | Fluorouracil |
| D016685 | Mitomycin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| 5-Fluorouracil | Drug | 5-FU will be delivered as 1000mg/m(2)/day as 96 hour continuous infusion beginning on day 1 and 29. |
|
|
| Mitomycin-C | Drug | Mitomycin-C (MMC) will be delivered at a dose of 10mg/m(2) on days 1 and 29 |
|
|
| Radiation Therapy | Procedure | Radiation therapy (RT) will be delivered to a total dose of 50-54 Gray (Gy) based on tumor characteristics. |
|
|
| baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks |
| Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | Number of participants that required a treatment break relative to hematologic (e.g. thrombocytopenia, leukopenia) toxicity (non-dermatologic). | From beginning until completion of radiation treatment up to 46 days |
| Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | Opiates are strong drugs prescribed by prescription used for maximum pain relief. | Completion of study, approximately 14 months after start of treatment |
| Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. | 12 months |
| Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment | Change in the levels of number of Human Immunodeficiency Virus (HIV) in the circulation pre and post treatment | Completion of study, approximately 14 months |
| Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | Ratio of the number Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) cells in the circulation and tissue pre and post treatment. The number of cells of CD4 are divided by the number of cells of CD8. | Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8) |
| Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | DFS is defined as the duration of time from start of treatment to time of progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. | 12 months |
| Overall Survival | OS is defined as the duration of time from start of treatment to time of death. | start of treatment to time of death, approximately 14 months |
| Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | Peripheral blood mononuclear cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor beta-1 (TGF-beta1) were sampled from peripheral blood from rectal associated lymphoid tissue to evaluate immune cell subsets at baseline and after treatment with MTS-0 and 15-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT). It is unknown if a lower or higher numbers has prognostic significance. | Baseline and Course 1 Day 28 |
| Number of Participants With Tumor Tissue Negative for Human Papilloma Virus (HPV) | HPV is a sexually transmitted infection that can cause warts and cervical cancer. HPV test detects deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) of HPV in a cell sample (i.e. cervical). | Pretreatment |
| Brief Pain Inventory Score | The Brief Pain Inventory Scale is a questionnaire that asks the participant to rate their pain on a scale of 0 (no pain) to 10 (worst pain). | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
| Pain Interference | The Brief Pain Inventory Scale questionnaire were used to assess pain interference. Participants rated pain interference on a scale of 0 (does not interfere) to 10 (completely interferes). | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
| Mean Percentage Pain Relief After Medication | The Brief Pain Inventory Scale questionnaire were used to assess pain relief after medication. Participants rated pain relief on a scale of 0% (no relief) to 100% (complete relief) and a mean and full range were reported. | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
| Duration of Overall Response (DOR) | Duration of overall response is measured from the time measurement criteria are met for Complete Response until the first date that recurrent or progressive disease is objectively document. Complete Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Complete Response is disappearance of all target lesions. | 12 months of follow up, approximately 14 months |
| Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue | Percentage of total viable cells that were Cluster of differentiation 3+ (CD3+) cells in biopsied tissue. | Baseline and 1 year |
| Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue | Absolute number of Cluster of differentiation 3+ (CD3) cells per gram of biopsied intestinal tissue. The number of CD3 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | Baseline and 1 year follow up |
| Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue | Number of Cluster of differentiation 8+ (CD8) cells per gram of biopsied intestinal tissue. The number of CD8 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | Baseline and 1 year follow up |
| Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue | Number of Cluster of Differentiation 4+ (CD4) cells per gram of biopsied intestinal tissue. The number of CD4 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | Baseline and 1 year follow up |
| Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa | Optional snag biopsies pre and post were collected from participants rectal mucosa to enumerate cell counts. | Baseline and Course 1 Day 28 |
| 19926961 | Background | Crum-Cianflone NF, Hullsiek KH, Marconi VC, Ganesan A, Weintrob A, Barthel RV, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Anal cancers among HIV-infected persons: HAART is not slowing rising incidence. AIDS. 2010 Feb 20;24(4):535-43. doi: 10.1097/QAD.0b013e328331f6e2. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG 0 is asymptomatic. ECOG 1 is symptomatic but ambulatory. ECOG 2 is <50% in bed. ECOG 3 is >50% in bed. ECOG 4 is bedbound. ECOG 5 is death. ECOG was not captured for one participant that withdrew before treatment. | ECOG data was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
| Human Immunodeficiency Virus (HIV) Status | HIV is a virus that attacks the body's immune system that can lead to serious illness and/or death. HIV positive = HIV test detected HIV in blood or saliva sample HIV negative = HIV test did not detect HIV in blood or saliva sample | HIV status was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
| Human Papilloma Status (Anal Swab) | HPV is a sexually transmitted infection that can cause warts and cervical cancer. HPV positive = HPV test detects deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) of HPV in cell sample HPV negative = HPV did not detect DNA or RNA of HPV in cell sample | HPV status was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
| T Stage | T Stage was measured by the American Joint Committee on Cancer (AJCC 7th Edition). T = tumor/describes size of original tumor T1-4 is increasing size and/or local extension of the primary tumor. | T Stage was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
| N Stage | N Stage was measured by the Stage American Joint Committee on Cancer (AJCC 7th Edition) N = node/cancer present in lymph nodes N0 = no lymph node metastases N1 = cancer spread to groin, rectum, and pelvic or external iliac nodes N2 = Metastasis in unilateral internal iliac and/or unilateral inguinal lymph node N3 = Metastasis in perirectal and inguinal lymph nodes and/or bilateral internal iliac and/or bilateral inguinal lymph nodes | N Stage was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
| Stage | Stage was measured by the American Joint Committee on Cancer (AJCC 7th Edition) Stage I - cancer has spread beyond to layer of anal tissue Stage II - tumor >2cm Stage III - cancer is any size but has not grown into nearby organs, or has spread into nearby organs Stage IV- most advanced stage of cancer; cancer is any size and may/may not have spread to nearby organs Stage V - | Stage was not captured for 1/6 participants that withdrew before treatment. | Count of Participants | Participants |
|
Grade 2 is moderate adverse events.
| OG002 | MTS-01 Grade 3 | Grade 3 is severe adverse events. |
| OG003 | 5FU/MMC/IMRT Grade 2 | Grade 2 is moderate adverse events. |
| OG004 | 5-FU/MMC/IMRT Grade 3-4 | Grade 3 is severe adverse events and Grade 4 is life threatening adverse events. |
|
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| Primary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | Date treatment consent signed to date off study, approximately, 36 months and 10 days. |
|
|
|
| Secondary | Mean Grade of Toxicity at Each Timepoint and Location for All Participants Who Underwent Treatment | RTOG grade 1-5 were used to assess skin toxicity in the groin (right and left inguinal area) and gluteal cleft, as well as two control sites. Grade 0 is no skin toxicity, Grade 1 is follicular, faint or dull erythema, Grade 3 is tender or bright erythema, Grade 3 is confluent, moist desquamation, Grade 4 is ulceration, hemorrhage, or necrosis, and Grade 5 is death due to radiation toxicity. | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Standard Deviation | Grade | baseline, weeks 1-6, follow up at 1 week, follow up at 2 weeks, and follow up at 4 weeks |
|
|
|
| Secondary | Number of Participants That Required a Treatment Break Relative to Hematologic Toxicity (Non-dermatologic) | Number of participants that required a treatment break relative to hematologic (e.g. thrombocytopenia, leukopenia) toxicity (non-dermatologic). | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | From beginning until completion of radiation treatment up to 46 days |
|
|
|
| Secondary | Number of Participants Treated With Topical MTS-01 and 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) That Required Opiates | Opiates are strong drugs prescribed by prescription used for maximum pain relief. | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | Completion of study, approximately 14 months after start of treatment |
|
|
|
| Secondary | Number of Participants With 12-month Progression-free Survival Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Change in the Levels of Number of Human Immunodeficiency Virus (HIV) in the Circulation Pre and Post Treatment | Change in the levels of number of Human Immunodeficiency Virus (HIV) in the circulation pre and post treatment | The participants were screened for HIV before enrollment. Only 1 participant was HIV positive. However, the participant with HIV came off study before post treatment was collected so change cannot be assessed. As pre-specified in the protocol, participants are taken off study for disease progression. | Posted | Completion of study, approximately 14 months |
|
|
| Secondary | Ratio of the Number of Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) Cells in the Circulation and Tissue Pre and Post Treatment | Ratio of the number Cluster of Differentiation 4 (CD4): Cluster of Differentiation 8 (CD8) cells in the circulation and tissue pre and post treatment. The number of cells of CD4 are divided by the number of cells of CD8. | 3/6 participants were analyzed because 1 participant was enrolled but withdrew before treatment, samples were collected at the time of optional biopsy which was conducted in 3 patients. | Posted | Mean | Full Range | Ratio of CD4:CD8 cells | Pre-treatment and post treatment tissue (CD4), and pre-treatment and post treatment circulation (CD8) |
|
|
|
| Secondary | Number of Participants With 12 Month Disease Free Survival (DFS) Treated With 5-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT) | DFS is defined as the duration of time from start of treatment to time of progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Overall Survival | OS is defined as the duration of time from start of treatment to time of death. | This outcome measure could not be completed. | Posted | Median | 95% Confidence Interval | months | start of treatment to time of death, approximately 14 months |
|
|
|
| Secondary | Peripheral Blood Mononuclear Cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor Beta-1 (TGF-beta1) Cell Counts at Baseline and Course 1 Day 28 | Peripheral blood mononuclear cells (Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Interleukin-7 (IL-7), and Transforming Growth Factor beta-1 (TGF-beta1) were sampled from peripheral blood from rectal associated lymphoid tissue to evaluate immune cell subsets at baseline and after treatment with MTS-0 and 15-Fluoruracil (5-FU)/Mitomycin C (MMC)/Intensity-modulated Radiotherapy (IMRT). It is unknown if a lower or higher numbers has prognostic significance. | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Standard Deviation | pg/ml | Baseline and Course 1 Day 28 |
|
|
|
| Secondary | Number of Participants With Tumor Tissue Negative for Human Papilloma Virus (HPV) | HPV is a sexually transmitted infection that can cause warts and cervical cancer. HPV test detects deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) of HPV in a cell sample (i.e. cervical). | 1/6 participants enrolled withdrew before treatment. | Posted | Count of Participants | Participants | Pretreatment |
|
|
|
| Secondary | Brief Pain Inventory Score | The Brief Pain Inventory Scale is a questionnaire that asks the participant to rate their pain on a scale of 0 (no pain) to 10 (worst pain). | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Full Range | Scores on a scale | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
|
|
|
| Secondary | Pain Interference | The Brief Pain Inventory Scale questionnaire were used to assess pain interference. Participants rated pain interference on a scale of 0 (does not interfere) to 10 (completely interferes). | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Full Range | Scores on a scale | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
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| Secondary | Mean Percentage Pain Relief After Medication | The Brief Pain Inventory Scale questionnaire were used to assess pain relief after medication. Participants rated pain relief on a scale of 0% (no relief) to 100% (complete relief) and a mean and full range were reported. | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Full Range | percentage pain relief | Baseline, Week 3, Week 6, 1 month follow up, and 3 months follow up |
|
|
|
| Secondary | Duration of Overall Response (DOR) | Duration of overall response is measured from the time measurement criteria are met for Complete Response until the first date that recurrent or progressive disease is objectively document. Complete Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST0 version 1.1. Complete Response is disappearance of all target lesions. | This outcome measure was not measurable. | Posted | Median | 95% Confidence Interval | months | 12 months of follow up, approximately 14 months |
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|
|
| Secondary | Percentage of Total Viable Cells That Were Cluster of Differentiation 3+ (CD3+) Cells in Biopsied Tissue | Percentage of total viable cells that were Cluster of differentiation 3+ (CD3+) cells in biopsied tissue. | 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy. | Posted | Mean | Full Range | percentage of cells | Baseline and 1 year |
|
|
|
| Secondary | Absolute Number of Cluster of Differentiation 3+ (CD3) Cells Per Gram of Biopsied Intestinal Tissue | Absolute number of Cluster of differentiation 3+ (CD3) cells per gram of biopsied intestinal tissue. The number of CD3 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy. | Posted | Mean | Full Range | CD3+cells/gm tissue(x 10^5) | Baseline and 1 year follow up |
|
|
|
| Secondary | Number of Cluster of Differentiation 8+ (CD8) Cells Per Gram of Biopsied Intestinal Tissue | Number of Cluster of differentiation 8+ (CD8) cells per gram of biopsied intestinal tissue. The number of CD8 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | 1/6 participants enrolled withdrew before treatment. 3 participants underwent optional biopsy. | Posted | Mean | Full Range | CD8+cells/gm tissue(x 10^5) | Baseline and 1 year follow up |
|
|
|
| Secondary | Number of Cluster of Differentiation 4+ (CD4) Cells Per Gram of Biopsied Intestinal Tissue | Number of Cluster of Differentiation 4+ (CD4) cells per gram of biopsied intestinal tissue. The number of CD4 positive cells were analyzed with flow cytometry of cellular suspensions from biopsy tissue. | 1/6 participants enrolled withdrew before treatment. | Posted | Mean | Full Range | CD4+cells/gm tissue(x 10^5) | Baseline and 1 year follow up |
|
|
|
| Secondary | Number of Participants With Human Immunodeficiency Virus (HIV) in Biopsy Tissue From Rectal Mucosa | Optional snag biopsies pre and post were collected from participants rectal mucosa to enumerate cell counts. | This outcome measure could not be completed. 1/6 participants enrolled withdrew before treatment. No participants with HIV ribonucleic acid (RNA) underwent optional biopsy. HIV RNA is not analyzed unless a patient has HIV. Thus, data not collected. | Posted | Baseline and Course 1 Day 28 |
|
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| 5 |
| 5 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other, Tongue deviation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Perineal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, Clamminess | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | - Other, Rash follicular, in and out of radiation and MTS-01 area |
|
| Skin and subcutaneous tissue disorders - Other, carbunkle | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, sweating | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013812 | Therapeutics |
| Week 1 |
|
| Week 2 |
|
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Follow up at 1 week |
|
| Follow up at 2 weeks |
|
| Follow up at 4 weeks |
|
|
| CD4:CD8 post treatment circulation |
|
| Title | Measurements |
|---|---|
|
| TNF-alpha at Course 1 Day 28 |
|
| IL-7 at baseline |
|
| IL-7 at Course 1 Day 28 |
|
| TGF-beta 1 at baseline |
|
| TGF-beta 1 at Course 1 Day 28 |
|
|
| Worst pain at 1 month follow up |
|
| Worst pain at 3 months follow up |
|
| Least pain at baseline |
|
| Least pain at treatment week 3 |
|
| least pain at treatment week 6 |
|
| Least pain at 1 month follow up |
|
| Least pain at 3 months follow up |
|
| Average pain at baseline |
|
| Average pain at treatment week 3 |
|
| Average pain at treatment week 6 |
|
| Average pain at 1 month follow up |
|
| Average pain at 3 months follow up |
|
| Pain at time of survey at baseline |
|
| Pain at time of survey at treatment week 3 |
|
| Pain at time of survey at treatment week 6 |
|
| Pain at time of survey a 1 month follow up |
|
| Pain at time of survey at 3 months follow up |
|
|
| Pain interference at 1 month follow up |
|
| Pain interference at 3 months follow up |
|
| Title | Measurements |
|---|---|
|
| 1 month follow up |
|
| 3 months follow up |
|