Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Skin Diseases

Recurrence

Melanoma

Carcinoma, Basal Cell

Skin Neoplasms

Lentigo

Hutchinson's Melanotic Freckle

Postoperative Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Disease Attributes

Neoplasms, Basal Cell

Melanosis

Hyperpigmentation

Pigmentation Disorders

Lentigo Maligna Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Formaldehyde

Patients treated with Mohs Micrographic Surgery in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Patients treated with Slow Mohs in the dermatology department of Maastricht University Medical Center +, Maastricht, the Netherlands

Treatment of a skin disease by Mohs micrographic surgery technique (frozen sections).

Mohs surgery

Treatment of a skin disease by Slow Mohs technique (formalin fixation and paraffin-embedded sections).

Slow Mohs surgery

Emmy Cruts, MD

E Cruts, MD

K Mosterd, MD, PhD

Mohs micro-graphic surgery (Mohs) is a tissue-sparing, surgical treatment for different types of skin cancer (e.g. basal cell carcinoma, squamous cell carcinoma, lentigo maligna (melanoma). It is a procedure performed with frozen sections. Slow Mohs, a variant of micro-graphic surgery, is performed by formalin fixation and paraffin-embedded sections. Both in Mohs and Slow Mohs tumor margins are assessed to achieve complete removal. This study aims to investigate the clinical presentation and outcomes (i.e. complications and recurrence rates) in patients treated with Mohs or Slow Mohs in the dermatology department of the Maastricht University Medical Center+ in Maastricht, the Netherlands.

Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs

Clinical Presentation and Surgical Outcomes in Patients With Skin Disorders Treated With Mohs Micrographic Surgery and Slow Mohs.

The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages.

The incidence of complications after Mohs and Slow Mohs, expressed as absolute numbers and percentages. Recurrence is defined as disease relapse after completion of treatment.

Predisposing factors (patient- and tumor characteristics) for complications after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize the presence of diabetes, tobacco use and medication use to be predisposing factors for complications.

Predisposing factors (patient- and tumor characteristics) for recurrences after Mohs and Slow Mohs, expressed in Hazard Ratio's and 95% confidence intervals. It is not possible to define the predisposing factors in advance, because this is currently unknown. We hypothesize incomplete treatment, worse prognostic tumor factors (Stage III of IV, presence of perineural invasion or lymphovascular invasion) to be predisposing factors for recurrence.

Maastricht University Medical Center

Melanoma, Cutaneous Malignant

Acral Lentiginous Melanoma

Superficial Spreading Melanoma

Nodular Melanoma

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Dinaciclib

Christopher D Lao

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.

SECONDARY OBJECTIVES:

I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.

III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Dinaciclib in Treating Patients With Stage IV Melanoma

A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.

National Cancer Institute (NCI)

SCH 727965

The median ans full range of those 72 patients' ages.

Age, Continuous

The gender summary of those 72 patients who have received Dinaciclib.

Sex: Female, Male

White

Asian

Pacific Islander

The race summary of 72 patients who have received Dinaciclib.

Race/Ethnicity, Customized

Unknown

The hispanic or non-hispanic summary of 72 patients who have received Dinaciclib.

Hispanic

The performance status of 72 patients who have received Dinaciclib. Only performance status 0 or 1 are included in the study.

Performance status 0: Fully active, able to carry on all pre-disease performance without restriction.

Performance status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

The higher score, the worse outcomes.

Performance Status

Bone

Brain

Liver

Lymph node, soft tissue, skin

Lung

Other visceral

Other non-visceral

Sites of metastases of 72 patients who have received Dinaciclib.

Site(s) of Metastases

Whether elevated LDH or not of 72 patients who have received Dinaciclib.

Elevated LDH

Cutaneous

Mucosal

Unknown primary

Primary type of melanoma of 72 patients who have received Dinaciclib.

Primary Type

Include all the patients that have received the treatment and been adverse event evaluable.

Melanoma Committee Statistician

Overall Survival

Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST

AST, SGOT

Cardiac troponin I (cTnI)

Cardiac-ischemia/infarction

Constitutional Symptoms-Other (Specify)

Dehydration

Diarrhea

Dyspnea (shortness of breath)

Edema: limb

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Hypotension

Hypoxia

Leukocytes (total WBC)

Lymphopenia

Metabolic/Laboratory-Other (Specify)

Mucositis/stomatitis (clinical exam) - Oral cavity

Muscle weakness, not d/t neuropathy - body/general

Nausea

Neutrophils/granulocytes (ANC/AGC)

Ocular/Visual-Other (Specify)

PTT (Partial thromboplastin time)

Pain - Abdomen NOS

Pain - Back

Pain - Cardiac/heart

Pain - Extremity-limb

Pain - Head/headache

Pain - Tumor pain

Prolonged QTc interval

Renal failure

SVT and nodal arrhythmia - Atrial fibrillation

SVT and nodal arrhythmia - Atrial flutter

SVT and nodal arrhythmia - Sinus tachycardia

Sodium, serum-low (hyponatremia)

Somnolence/depressed level of consciousness

Syncope (fainting)

Thrombosis/thrombus/embolism

Vascular-Other (Specify)

Vision-blurred vision

Vomiting

Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs	NCT06014619	Skin Cancer Complication Complication of... Complication,Po... Recurrence Recurrent Disea... Cutaneous Squam... Basal Cell Carc... Lentigo Maligna Lentigo Maligna...	Mohs surgery Slow Mohs surge...	16 Years -	Maastricht University Medical Center
Dinaciclib in Treating Patients With Stage IV Melanoma	NCT00937937	Acral Lentigino... Cutaneous Nodul... Lentigo Maligna... Low-CSD Melanom... Mucosal Melanom... Recurrent Melan... Stage IV Cutane...	Dinaciclib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for lentigo maligna melanoma