Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Formaldehyde

Lonafarnib

Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.

Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.

Tumor Sample

Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Serum Sample

George Sledge, M.D.

This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.

OUTLINE: This is a multi-center study.

Sample Collection:

* Tumor sample
* Serum sample

Treatment Regimen:

* All registered patients must be planning treatment with lonafarnib

Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

United States Department of Defense

Indiana University School of Medicine

Emory University

Hoosier Cancer Research Network

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Blood samples will be collected. Tumor samples will be collected using a small needle, a punch knife, or a small surgery.

Blood Sample

Tumor samples will be collected using a small needle, a punch knife, or a small surgery.

Michael Davies, MD

The goal of this laboratory research study is to collect blood and tumor samples from patients with malignant melanoma. Researchers want to store these samples in a secure and confidential laboratory at M. D. Anderson. Researchers will use the information that is learned in this study to help find ways to improve treatment for melanoma and other cancers.

Researchers at M. D. Anderson want to learn as much as possible about melanoma and other cancers. One way researchers can learn more about cancer is by studying what is in your blood and in your tumor.

If you agree to take part in this study, the way you participate will depend on if you are being treated for cancer. If you are receiving any form of chemotherapy, you will have about 4 1/2 tablespoons of blood drawn before you start the first day of treatment. You will then have about 3 tablespoons of blood drawn every 6 to 8 weeks for the next 6 months. You will have a total of up to about 5 blood draws for this portion of the study. You will have the above blood draws during routine visits so that no additional visits will be required.

If you are receiving "immunologic or targeted" cancer treatment, you will have blood drawn for testing. Immunologic treatment is a kind of treatment which boosts your immune system to fight your cancer. Targeted cancer treatment is a kind of treatment which disrupts the functions of proteins that are needed for tumor growth. About 4 1/2 tablespoons of blood drawn before you start the first day of treatment. You will then have about 3 tablespoons of blood drawn 1 time during the first 2 weeks (Days 2-14), 1 time during the second 2 weeks (Days 15-28), 1 time during second or third month (Days 29 - 90), and then once every 3 months for up to 5 years. A total of no more than 25 samples will be drawn.

After the 6-month period, if follow-up is scheduled for you at M. D. Anderson, you will have about 3 tablespoons of blood drawn (during the follow-up visits) once every 3 months for the next 5 years. You will have a total of 20 blood draws for this portion of the study. During your follow-up, you will have a routine clinic visit to monitor any tumor recurrences (occurring again). You will continue to have this visit about every 2 to 6 months, depending on the risk of any tumor recurrence.

If you are not receiving any form of cancer treatment, you will have about 4 1/2 tablespoons of blood drawn on the day that you enroll in this study. If you agree (it is your choice) to participate in the follow-up portion of this study, you will have about 3 tablespoons of blood drawn (during the follow-up visits) once every 3 months for the next 5 years. You will have a total of about 21 blood draws for this portion of the study.

If you do not agree to take part in the additional follow-up, your participation in this study will be over.

If you are planning to have surgery to remove your tumor as part of your standard care, some of your tumor samples will be collected at that time and stored in a secure and confidential laboratory at M. D. Anderson. If the tumor samples are too small, the whole tumor sample will be sent to a doctor for a diagnostic evaluation. If this is the case, researchers will not use any of your tumor sample for this study.

If you have tumors like skin lesions or lymph node lesions that are located close to the skin, and you plan to have cancer treatment, a sample of your tumor will be collected before you receive your cancer treatment. It will also be collected up to 2 other times (for this study's research), while you are on treatment. A total number of biopsy will not exceed 6 per year, and will not exceed more than 10 over 5 year period. The biopsies will be performed by using a small needle (with or without an ultrasound imaging machine), a punch knife, or a small surgery. If you have tumors located close to the skin but do not plan to receive cancer treatment, you will be asked to have a tumor biopsy up to 2 times per year for up to 5 years.

Before your blood and tumor samples can be used for research, the people doing the research must get specific approval from the institutional review board (IRB) of M. D. Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at M. D. Anderson, including research involving your blood and/or tumor samples from this bank, must first be approved by the IRB.

This is an investigational study. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.

Patients will provide blood and tumor samples to help researchers learn about melanoma and other cancers.

Sample Collection From Melanoma Patients

Blood and Tumor Sample Collection From Patients With Malignant Melanoma for Long Term Storage

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Gland Diseases

Endocrine System Diseases

Adrenal Cancer

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

These patients will be followed up and proposed a search for targetable molecular alterations

For patients with ACC : blood (30ml) sampling before surgery and every 3 months during 3 years after surgery for biobanking For patients with MPP : blood (30ml) sampling before surgery and every 6 to 12 months for MPP during 3 years after surgery for biobanking

Blood sample

For patients with ACC : urine sampling before surgery and every 3 months during 3 years after surgery for biobanking For patients with MPP : urine sampling before surgery and every 6 to 12 months for MPP during 3 years after surgery for biobanking

Urine sample

For patients with ACC and patients with MPP : tumor sample during surgery

Tumor sample

Guillaume Assie, Pr

Christelle AUGER, Chef de projet

Guillaume ASSIE, Pr

Anne JOUINOT, Dr

The adrenal cancer research network "COMETE" is federating French research on rare adrenal cancers. COMETE achieved major breakthroughs in the molecular characterization of adrenocortical carcinomas (ACC) and malignant pheochromocytomas/paragangliomas (MPP). Recently, COMETE successfully derived potential biomarkers for prognosis, theranostic and follow-up. Those biomarkers have been retrospectively validated. However the benefit for patients in real life conditions is not yet established.

* Main objective : to implement COMETE biomarkers as a routine standard of care for adrenal cancer.
* The primary end point is double :

  * Proportion of biomarkers results provided within 3 months after surgery,
  * The proportion of "informative" biomarkers, corresponding to markers passing quality controls and returning a value that is not in the grey zone of the measure.
* Secondary objective : to estimate the impact of COMETE biomarkers on patients management.
* Secondary endpoints :

  * Proportion of patients with discrepant clinical and molecular markers ; for discrepancies, proportion of decisions impacted by biomarkers results
  * Proportion of high risk patients for whom an actionable molecular target was identified
  * Predictive value (positive and negative) of biomarkers to detect recurrences
  * Molecular signatures of "extraordinary responders" to treatments (corresponding to the exceptional RECIST complete response, or to the \>80% tumor reduction sutained for \>6months)

* Adult patients with a malignant adrenal tumor before initial surgery are proposed to participate to the study.
* Initial clinical management following current guidelines is applied, including clinical and morphological evaluation, hormone assays and adrenal surgery. A tumor sample from initial surgery , and a blood sample and a urine sample collected before surgery are included in the current research protocol. These samples are used to run prognostic molecular measurements, in order to classify patients as "low" or "high risk" of recurrence. For ACC samples, paraffin tumor samples will be sent to a centralized pathology facility, where 3' RNA sequencing will be performed on tumor RNA to classify tumors into previously established C1A/C1B prognostic classification. Circulating levels of miRNAs will be assayed from blood samples collected before surgery and used to classify tumors into prognostic categories as previously reported. Urine and plasma steroids profiles will be established using mass spectrometry to classify tumors into prognostic categories as previously reported. For MPP, molecular assays will include somatic genotyping, methylation assays and immunochemistry for the known recurrently altered genes, and used to classify tumors into prognostic categories as previously reported. These molecular results are returned by 3 months after surgery
* Patients follow-up is then performed following current guidelines, with repeated visits (each \~3 months for ACC and \~6 months for MPP), including clinical, morphological evaluation, and hormone assays. A blood and a urine sample will also be collected for the current research protocol. These samples will be used to run molecular measurements aiming at identifying early recurrence. For ACC, circulating levels of miRNAs and urine and plasma steroids profiles will be measured every 3 months to classify tumors into prognostic categories as previously reported. For MPP, circulating levels of miRNAs will be measured every 6 months to classify tumors into prognostic categories as previously reported
* For patients at high risk of recurrence, a molecular target will be searched by an extended genomic analysis of the tumor (exome sequencing and RNA sequencing), in search for molecular targets that may orient future treatments, if the disease recurs.

Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M18 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M21 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M24 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M27 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M30 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M33 follow-up visit

Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M36 follow-up visit

National Cancer Institute, France

Assistance Publique - Hôpitaux de Paris

Nervous System Diseases

Glioblastoma

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Antineoplastic Agents

Temozolomide

Five blood sample in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma

Emeline TABOURET, PH

Dominique FIGARELLA, PU-PH

Olivier CHINOT, PU-PH

Philippe METELLUS, PU-PH

Jean-Olivier ARNAUD, Director

Glioblastoma is the most frequent and aggressive primary brain tumor in adults. A team recently showed that baseline plasma levels of matrix metalloproteinase-2 (MMP2) and matrix metalloproteinase-9 (MMP9) were correlated to bevacizumab activity in patients with recurrent glioblastoma. To date, the biological rationale of this results remains unknown but MMP2 could be involved in classical angiogenesis while MMP9 could promote vasculogenesis.

The objectives are to correlate the plasma levels of MMP2 and MMP9 to their Ribonucleic acid (RNA) and protein tissue expression, activity and to patient neuro-imaging features. To analyze the changes of MMP2 and MMP9 plasma levels during peri-operative period and after radio-chemotherapy.

Methods: Plasmatic levels of MMP2, MMP9, vascular endothelial growth factor-A (VEGFA), vascular endothelial growth factor-R2 (VEGFR2), stromal cell-derived factor 1 (SDF1) and chemokine receptor-4 (CXCR4) will be analyzed by enzyme-linked immunosorbent assay (ELISA) in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma. RNA expression of these factors will be analyzed by reverse transcription-Polymerase chain reaction (RT-qPCR) on frozen tumor samples, whereas protein expression will be analyzed by ELISA and immunohistochemistry. Enzymatic activity of MMP2 and MMP9 will be analyzed by zymography. Tumor volume, infiltration and perfusion degrees will be analyzed on Magnetic Resonance Imaging (MRI) performed before and after surgery and before adjuvant temozolomide. Neuro-imaging characteristics will be correlated to plasma and tissue expressions of these factors.

The expected results are to better define the expression profile of MMP2, MMP9 and the change in their plasma level during treatment, a prerequisite for their clinical use.

Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.

identify potential temporal variations of these markers

Assistance Publique Hopitaux De Marseille

Anaplastic Astrocytoma

MRI examination with i.v. gadolinium contrast to assess blood perfusion in remaining tumor tissue.

Functional MRI (DCE-MRI)

Hans Petter Eikesdal, MD PhD

The purpose of the current trial is to explore whether the standard treatment with radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival.

Today's standard treatment with radiotherapy and temozolomide yields a life expectancy of 1.5-3 years in patients with high-grade astrocytomas. Thus, there is a need for further therapeutic improvements in this patient population. The purpose of the current trial is to explore whether radiotherapy and temozolomide affect the tumor vasculature in patients with high-grade astrocytomas. If vascular effects are identified, future clinical trials can be proposed wherein anti-angiogenic agents are added to increase patient survival. Additionally, stem cells within malignant brain tumors is an important new area of research in this patient population, and investigations herein could contribute to identify new predictive markers and therapeutic targets.

Primary objective: To assess the vascular perfusion and permeability characteristics of high-grade astrocytomas (anaplastic astrocytoma and glioblastoma multiforme) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in patients receiving radiotherapy and temozolomide. Furthermore to assess whether therapy-induced changes in tumor perfusion is correlated with progression-free survival.

Secondary objectives:

* Analyze circulating endothelial cells in the blood by flow cytometry to explore whether these cells can be used as an indirect estimate of angiogenesis in high-grade astrocytomas
* Analyze tumor specimens from patients that have had their gliomas debulked before commencing therapy

  * immunostaining of the tumor vasculature to assess microvessel density
  * immunostaining for tumor stem cells
  * flow cytometric assessment of dissolved tumor tissue to look for tumor stem cells
* Assess progression-free survival of all patients included in the study, in order to correlate the survival data with the above tissue sampling results.

Tumor samples and blood samples are collected and frozen for future analysis for tumor vascularization and tumor stem cells.

The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas

Only one patient was included before the study was terminated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer	NCT01232881	Breast Cancer	Tumor Sample Serum Sample	18 Years -	Hoosier Cancer Research Network
Sample Collection From Melanoma Patients	NCT00507325	Melanoma	Blood Sample Tumor Sample	-	M.D. Anderson Cancer Center
Sample Collection From Melanoma Patients	NCT00507325	Melanoma	Blood Sample Tumor Sample	-	M.D. Anderson Cancer Center
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)	NCT05754892	Cancer Adrenal	Blood sample Urine sample Tumor sample	18 Years -	Assistance Publique - Hôpitaux de Paris
Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.	NCT03526822	Brain Tumor	Blood sample Tumor sample	18 Years -	Assistance Publique Hopitaux De Marseille
Sample Collection From Melanoma Patients	NCT00507325	Melanoma	Blood Sample Tumor Sample	-	M.D. Anderson Cancer Center
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)	NCT05754892	Cancer Adrenal	Blood sample Urine sample Tumor sample	18 Years -	Assistance Publique - Hôpitaux de Paris
Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.	NCT03526822	Brain Tumor	Blood sample Tumor sample	18 Years -	Assistance Publique Hopitaux De Marseille
Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.	NCT03526822	Brain Tumor	Blood sample Tumor sample	18 Years -	Assistance Publique Hopitaux De Marseille
The Effect of Radiotherapy and Temozolomide on the Tumor Vasculature and Stem Cells in Human High-grade Astrocytomas	NCT00473408	Anaplastic Astr... Glioblastoma Mu... Tumor Angiogene...	Functional MRI ... Blood sample Tumor sample	18 Years -	Haukeland University Hospital
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer	NCT01232881	Breast Cancer	Tumor Sample Serum Sample	18 Years -	Hoosier Cancer Research Network

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