Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Syndrome

Leukemia

Mastocytosis

Gastrointestinal Stromal Tumors

Hypersensitivity

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Mastocytosis, Systemic

Hypereosinophilic Syndrome

Dermatofibrosarcoma

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Eosinophilia

Leukocyte Disorders

Fibrosarcoma

Neoplasms, Fibrous Tissue

Sarcoma

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Systemic Mastocytosis

Dermatofibrosarcoma Protuberans

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

imatinib mesylate

Novartis Pharmaceuticals

This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.

Condition

Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.

Not included:

Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.

Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes

Recurrence

Imatinib (Glivec)

Selma Ugurel, MD

Dirk Schadendorf, MD

The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).

This study is aimed to investigate the efficacy of imatinib (Glivec) in the treatment of primary and locally relapsed dermatofibrosarcoma protuberans (DFSP). DFSP is a cutaneous neoplasm well known for its overexpression of the platelet-derived growth factor (PDGF). Herein, imatinib provides a systemic treatment option that offers the possibility of a reduction of the wide surgical margins used today in surgery of primary DFSP, or even of a complete avoidance of surgical treatment in this disease. Since imatinib exerts its function via interference with protein tyrosine kinase activities, it inhibits the platelet-derived growth factor receptor (PDGF-R) signaling cascade that plays a crucial role in the pathogenesis and tumor growth of DFSP. Since imatinib has been shown to shrink metastatic lesions of DFSP, there is a strong rationale to expect that it also decreases cell proliferation and tumor growth in primary DFSP.

Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans

Dermatologic Cooperative Oncology Group

Melanoma

Fibromatosis, Aggressive

Carcinoma, Adenoid Cystic

Chordoma

Ocular Melanoma

Desmoid Tumor

Adenoid Cystic Carcinoma

Conjunctival Melanoma

Antirheumatic Agents

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 400 mg/day, per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

Imatinib mesylate, Cyclophosphamide (Dosing level 1 )

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os

Imatinib mesylate, Cyclophosphamide (Dosing level 2)

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os

Imatinib mesylate, Cyclophosphamide (Dosing level 3)

ONLY FOR CYCLE 1, at day 15 and day 28 :

11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)

Blood sampling

Antoine ADENIS, MD, PhD

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

Centre Oscar Lambret

Carcinoma

Carcinoma, Squamous Cell

Carcinoma, Basal Cell

Histiocytoma, Malignant Fibrous

Skin Neoplasms

Histiocytoma

Neoplasms, Adnexal and Skin Appendage

Neoplasms, Glandular and Epithelial

Skin Diseases

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Patients treated using Mohs surgery. Other exposures considered include patient characteristics, preoperative care and technical variants.

A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.

Mohs surgery

Ignacio Garcia-Doval, MD, PhD

REGESMOHS (Registro Español de cirugía de Mohs) aims at describing effectiveness of Mohs surgery, and patient, tumor and technique factors related to adverse events and tumor recurrence.

REGESMOHS is a prospective cohort, including all patients considered for Mohs surgery in participating centers. All consecutive patients are included. The only exclusion criteria are being under 18-years-old or legally incompetent. Pre-planned follow-up is as required by common clinical practice, but at least once a year for the study period.

Spanish Registry of Mohs Surgery

Spanish Registry of Mohs Surgery [Registro Español de Cirugía de Mohs]

Bleeding, infection, abnormal scar, necrosis

Need for admission, type of anesthesia, number of surgical steps, participating doctors,time in surgery room.

presence of: abnormal scar, ectropion, nostril alteration, oral sphincter incompetence,other

Roche Pharma AG

Fundación Academia Española de Dermatología

Administration of pazopanib per os 800mg/ qd during 6 months until stable response according to primary endpoint, with 3 monthly successive examinations, and for a period of study not exceeding 18 months.

Pazopanib

Celeste LEBBE, MD-PhD

In relation to the activation of PDGF-mediated signalization due to the fusion gene COL1A1-PDGFb in DFSP, imatinib (800mg/day) has shown activity in advanced DFSP and has became the reference treatment option for these patients. Yet the activity observed does not allow for a downstaging compatible with successful resection in a number of patients and does not prevent subsequent tumour progression in case of residual tumour.Pazopanib in relation to 1) its multi tyrosine kinase inhibiting activity (VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-α, PDGFR-β and c-kit with IC50 values of 10, 30, 47, 71, 84, and 74 nM, respectively) involving in particular PDGFR, and VEGFR which has been shown to be activated in DFSP, 2) its antitumour activity in sarcomas patients, and 3) its acceptable safety profile, is a logical candidate for therapeutic trials in DFSP both in patients not expected to derive a sufficient benefit from imatinib and in patients failing imatinib mesylate. Moreover, using quantitative RT-PCR and immunohistochemistry we have recently demonstrated high levels of VEGF and VEGFR2 expression in dermatofibrosarcoma.

Dermatofibrosarcoma protuberance (DFSP) is a rare soft tissue sarcoma of intermediate malignant potential. Treatment relies on a wide local excision with negative margin and with frequent need of reconstructive surgery. A translocation between chromosomes 17 and 22 that places the platelet-derived growth factor-B (PDGFB) under the control of the collagen 1A1 promoter is present in \> 90 % of the cases leading to an up regulation of PDGF-β expression and activation of the tyrosinase kinase PDGFRβ. Imatinib mesylate has been approved in unresectable and metastatic DFSP due to its activity on PDGFR. This study will evaluate the benefit of pazopanib, a multikinase inhibitor in advanced DFSP. Administration of pazopanib per os 800mg/ qd during 6 months until stable response according to primary endpoint , and for a period of study not exceeding one year.In case of progression evaluated according to the primary endpoint after a period of treatment superior to one month, or in the absence of response at 3 months, the patient will be withdrawn from study, in order to get alternative therapeutics. These patients will be considered as failures for analysis. After a 6-month treatment period, and reaching a stable response, treatment continuation decision will be based on the operability of patients.

Administration of pazopanib per os 800mg/ qd during 6 months until stable response according to primary endpoint, with 3 monthly successive examinations, and for a period of study not exceeding 18 months.In case of progression evaluated according to the primary endpoint after a period of treatment superior to one month, or in the absence of response at 3 months, the patient will be withdrawn from study, in order to get alternative therapeutics. These patients will be considered as failures for analysis. After a 6-month treatment period, and reaching a stable response, treatment continuation decision will be based on the operability of patients Statistical analysis : The trial has been planned using a one-stage design (Fleming TR. Et al) Analysis of the main endpoint will rely on a one-sided binomial test comparing the observed response rate to the expected response rate under the null hypothesis . The type I error rate is fixed at 0.025.For the main endpoint, a point estimate and a two-sided 90% confidence interval will be presented, which will be consistent with the one-sided test at a 0.025 level. For secondary endpoints, point estimates and 95% confidence intervals will be presented.We intend to estimate the probability of tumour size reduction of at least 30%. The sample size was calculated by FLEMMING method : Ho will be defined by a RR ≤20% (decrease in tumour size of at least 30%) , H1 , response rate, 26 patients must be included in order to demonstrate an efficacy as defined by a RR≥50%, with a 90% power and alfa 2.5% one side.

Phase II Pazopanib Study in Advanced Dermatofibrosarcomas

A Phase IIa Open Multicenter, Trial, of Treatment With Pazopanib (Multi Tyrosine Kinase Inhibitor) in Dermatofibrosarcomas (DFSP), Unresectable Locally Advanced (Potentially Mutilating Surgery), Primary or Relapsing , Transformed or Not.

GlaxoSmithKline

Assistance Publique - Hôpitaux de Paris

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes	NCT00171912	Hypereosinophil... Systemic Mastoc... Chronic Myelomo... Dermatofibrosar...	imatinib mesyla...	16 Years - 80 Years	Novartis
Imatinib in Dermatofibrosarcoma Protuberans (DFSP)	NCT00122473	Dermatofibrosar...	Imatinib (Glive...	18 Years -	Dermatologic Cooperative Oncology Group
Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate	NCT01046487	Cancer	Imatinib mesyla... Imatinib mesyla... Imatinib mesyla... Blood sampling	18 Years -	Centre Oscar Lambret
Spanish Registry of Mohs Surgery	NCT02310503	Skin Neoplasms Carcinoma, Basa... Carcinoma, Squa... Dermatofibrosar... Melanoma Histiocytoma, M... Neoplasms, Adne...	Mohs surgery	18 Years -	Fundación Academia Española de Dermatología
Phase II Pazopanib Study in Advanced Dermatofibrosarcomas	NCT01059656	Dermatofibrosar...	Pazopanib	20 Years -	Assistance Publique - Hôpitaux de Paris
Spanish Registry of Mohs Surgery	NCT02310503	Skin Neoplasms Carcinoma, Basa... Carcinoma, Squa... Dermatofibrosar... Melanoma Histiocytoma, M... Neoplasms, Adne...	Mohs surgery	18 Years -	Fundación Academia Española de Dermatología

Spots Global Cancer Trial Database for dermatofibrosarcoma