Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Anti-Inflammatory Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Infective Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Anti-Bacterial Agents

Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval

phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)

Clindamycin Phosphate

triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change

Alina Markova, MD

Rashek Kazi, MD,PhD

Priya Kumthekar, MD

Deric M Park, MD, FACP

Rashek Kazi, MD, PhD

The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.

This is a phase 2, multicenter, open-label study.

Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

device-related skin adverse events by investigator assessment.

using the PRO-CTCAE for rash, ulcer, and pruritus.

Memorial Sloan Kettering Cancer Center

Skin and Connective Tissue Diseases

Head and Neck Neoplasms

Exanthema

Skin Diseases

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Dermatologic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cetuximab

Doxycycline

Prednisolone

Antibiotics, Antitubercular

Methylprednisolone

Sunscreening Agents

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Tetracycline

Minocycline

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Protective Agents

Antineoplastic Agents, Hormonal

Radiation-Protective Agents

Doxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening.

For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use.

For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended.

For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment.

Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.

Doxycycline capsule, 100 mg, taken twice daily

Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)

Hydrocortisone 1% cream

Applied to exposed skin areas at least 30 minutes before going outdoors each morning.

Sunscreen

Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen

Moisturizer

Recommended for daily use if rash returns (Topical cream)

Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.

Medrol-dose pack (Steroid)

Rebecca A. Redman, MD

The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest each evening.

Subjects will start taking the capsule and applying the creams three days prior to beginning cetuximab therapy. They will continue this regimen of taking the capsule and applying the creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the study doctor may decide to reduce the amount of the dose of cetuximab that they receive or prescribe other medicines according to standard treatment recommendations, just as he/she would if the subject was not participating in this study. Subjects will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

The standard care group will not receive preventive treatment, but they will be allowed to use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

If a subject is assigned to this group and they develop a severe skin rash, the study doctor will treat their rash according to standard treatment recommendations, which may include Hydrocortisone 1% cream, Doxycycline capsules or other medications.

There will be a follow-Up period for both extensive treatment and standard care groups. At 6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study treatment period, they will be contacted by telephone or discussed during their routine clinic visit.

Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients

Evaluate the incidence of cetuximab-induced rash, Compare the severity of cetuximab-induced rash between the extensive treatment group (ETG) and the standard care group (SCG).

Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group.

Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group

Estimate and compare Progression-Free Survival (PFS) in extensive treatment group and standard treatment group. Survival follow-ups will be at 6 months, 12 months, 18 months, and 24 months post treatment.

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Paronychia

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Chlorhexidine

Chlorhexidine gluconate

Mitogens

Lazertinib

Amivantamab-vmjw

Anti-Infective Agents, Local

Disinfectants

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

Participants will receive enhanced dermatologic management to reduce dermatologic toxicities in skin and nail with oral doxycycline tablet or minocycline capsule (100 milligrams \[mg\] twice daily for 12 weeks), clindamycin 1 percent (%) topical lotion, chlorhexidine 4% topical solution, and noncomedogenic skin moisturizer (once daily, sufficient quantity to cover skin) during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab (1050 mg for body weight less than \[\<\] 80 kilograms \[kg\] and 1400 mg for body weight greater than or equal to \[\>=\] 80 kg as intravenous \[IV\] infusion, once weekly for the first 4 weeks and then once every 2 weeks) and lazertinib (240 mg, tablet, once daily) until documented disease progression using Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1).

Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab plus lazertinib.

Amivantamab will be administered as intravenous (IV) infusion.

Amivantamab

Lazertinib tablet will be administered orally.

Doxycycline tablet will be administered orally.

Minocycline capsule will be administered orally.

Clindamycin lotion will be used as topical application on the scalp.

Chlorhexidine solution will be used as topical application on hands and feet.

Noncomedogenic skin moisturizer will be used as topical application.

Noncomedogenic skin moisturizer

Study Contact

Janssen Research & Development, LLC Clinical Trial

The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib.

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Number of participants with Grade \>= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

Number of participants with DAEIs by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with Grade \>=2 DAEIs within 6 months after initiation of anticancer treatment based on NCI CTCAE v 5.0 will be reported.

Time to first occurrence of Grade \>=2 DAEI will be reported.

Number of participants with paronychia by severity based on NCI CTCAE v 5.0 will be reported.

Number of participants with scalp rash by severity based on NCI CTCAE v 5.0 will be reported.

Change from baseline in skindex symptoms domain score up to 12 months will be reported. The score of quality of life will be assessed using the Skindex-16 questionnaire. Skindex-16 is used for participants to rate skin conditions.

Change from baseline in PGI-S rash up to 12 months will be reported. Participant quality of life will be evaluated using PGI-S Rash. PGI-S is a single-item questionnaire assessing participants disease severity on a 7-point response scale.

Change from baseline in EORTC-QLQ-C30 score up to 12 months will be reported. EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies.

Percentage of participants with dose reductions, dose interruptions, and dose discontinuations of anticancer treatment due to DAEIs will be reported.

Relative dose intensity of anticancer treatment will be reported. The relative dose intensity is defined as the ratio of total actually received dose versus total prescribed dose.

Percentage of participants with VTE AEs (pulmonary embolism and deep vein thrombosis) by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Percentage of participants with AEs by severity based on NCI CTCAE v 5.0 will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause, whichever occurs first.

ORR is defined as the percentage of participants who achieve a partial response (PR) or better response using RECIST v1.1 as assessed by the investigator.

DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the RECIST v1.1 response criteria.

Janssen Research & Development, LLC

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Communicable Diseases

Urinary Tract Infections

Disease Attributes

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urinary Bladder Diseases

Anti-Dyskinesia Agents

Micronutrients

Hematinics

Vitamins

Levofloxacin

Ofloxacin

Nitrofurantoin

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Ertapenem

Cytochrome P-450 Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Diary

Trimethoprim-Sulfamethoxazole

Khurshid A. Guru

Khurshid A Guru

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields	NCT04469075	Glioblastoma Recurrent Gliob... Skin Toxicity	Clindamycin Pho... Triamcinolone A...	18 Years -	Memorial Sloan Kettering Cancer Center
Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients	NCT01874860	Colorectal Canc... Head and Neck C...	Doxycycline Hydrocortisone ... Sunscreen Moisturizer Clindamycin Medrol-dose pac...	18 Years -	University of Louisville
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib	NCT06120140	Carcinoma, Non-...	Amivantamab Lazertinib Doxycycline Minocycline Clindamycin Chlorhexidine Noncomedogenic ...	18 Years -	Janssen Research & Development, LLC

Spots Global Cancer Trial Database for clindamycin

Every month we try and update this database with for clindamycin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for clindamycin

Every month we try and update this database with for clindamycin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clindamycin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.