Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Antibodies

Antibodies, Monoclonal

Fluorides

Immunoglobulins

Sunitinib

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive sunitinib malate PO on days 1-28 and bevacizumab IV over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

sunitinib malate

bevacizumab

pharmacological study

laboratory biomarker analysis

fluorine F 18 fluorothymidine

positron emission tomography

computed tomography

Glenn Liu

This phase I trial studies the side effects and the best dose of sunitinib malate when given together with bevacizumab in treating patients with kidney cancer or advanced solid malignancies. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving sunitinib malate together with bevacizumab may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of sequential sunitinib (sunitinib malate) with bevacizumab in patients with clear cell kidney cancer.

II. To assess the objective response rate of sequential sunitinib with bevacizumab in patients with clear cell kidney cancer.

SECONDARY OBJECTIVES:

I. To determine the pharmacodynamic change in standardized uptake values (SUV) peak and tumor perfusion using fluorine F 18 fluorothymidine positron emission tomography (FLT-PET)/computed tomography (CT) scans at baseline, during sunitinib exposure, and during bevacizumab exposure (during sunitinib withdrawal period) in patients with renal cell and other solid malignancies.

II. To characterize changes in the ratio of free: bound plasma vascular endothelial growth factor (VEGF) in patients treated with sequential sunitinib with bevacizumab.

OUTLINE: This is a dose-escalation study of sunitinib malate.

Patients receive sunitinib malate orally (PO) on days 1-28 and bevacizumab intravenously (IV) over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies

Phase I Pharmacodynamic Trial of Sequential Sunitinib With Bevacizumab in Patients With Renal Cell Carcinoma and Other Advanced Solid Malignancies

Responses will be summarized using descriptive statistics and frequency tables. Two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response will be computed for the two treatment schedules of sunitinib malate

Summarized in terms of means, standard deviations and ranges. Percentage changes will be computed and formally compared using paired t-tests and/or the nonparametric Wilcoxon Signed Rank test, should the normality assumption be violated.

Plasma VEGF will be summarized using descriptive statistics such as means, standard deviations and ranges. Changes from baseline will be evaluated using paired t-tests and/or nonparametric Wilcoxon Signed Rank tests, should the normality assumption be violated and should no normality-improving transformation be found

National Cancer Institute (NCI)

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antirheumatic Agents

Gold Sodium Thiomalate

gold sodium thiomalate

gene expression analysis

mass spectrometry

Julian Molina, MD, PhD

RATIONALE: Gold sodium thiomalate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gold sodium thiomalate in treating patients with advanced non-small cell lung cancer.

OBJECTIVES:

* To determine the maximum tolerated dose of gold sodium thiomalate in patients with advanced non-small cell lung cancer.
* To describe the toxicities associated with this treatment.
* To describe any preliminary evidence of biologic activity.
* To further assess the correlation between PKCι expression and the antitumor effects of gold sodium thiomalate.
* To study the association of clinical (toxicity and/or tumor response or activity) with pharmacokinetic/pharmacodynamic parameters.
* To describe anti-proliferative activity of gold sodium thiomalate through 3-deoxy-3-\[\^18F\]-fluorothymidine positron emission tomography imaging.

OUTLINE: This is a dose-escalation study of gold sodium thiomalate.

Patients receive gold sodium thiomalate intramuscularly on days 1, 8, 15 and 22. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive gold sodium thiomalate once every 4 weeks until a total cumulative dose of 1 gram is delivered.

Blood samples are collected at baseline and prior to therapy in weeks 3, 5, 7, 9, and 11. Samples are analyzed by mass spectometry for pharmacokinetics. Paraffin-embedded tumor tissue samples are analyzed for PKC_l expression and antitumor activity. Antiproliferative effects of gold sodium thiomalate are analyzed by 3-deoxy-3-\[\^18F\]-fluorothymidine positron emission tomography imaging.

Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Phase I Dose Escalation Study of the PKC Inhibitor, Aurothiomalate (ATM) in Patients With Advanced Non-Small Cell Lung Cancer

Mayo Clinic

Nervous System Diseases

Glioblastoma

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Astrocytoma

Ependymoma

Oligodendroglioma

Gliosarcoma

Brain Tumor, Adult

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Diffuse Astrocytoma

Anaplastic Ependymoma

Protective Agents

Alexander M. Spence, MD

RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine F 18, may be effective in finding recurrent disease in patients with gliomas.

PURPOSE: This clinical trial is studying how well positron emission tomography using fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.

OBJECTIVES:

Primary

* Determine the safety of fluorothymidine F 18 for visual and dynamic brain tumor images in patients with glial neoplasms.
* Determine, preliminarily, the efficacy of this drug.

Secondary

* Compare, preliminarily, the efficacy of this drug to fludeoxyglucose F 18 in differentiating tumor recurrence from radiation necrosis.
* Determine the optimal time to image post injection of this drug.

OUTLINE: This is a pilot, nonrandomized study.

Patients receive fluorothymidine F 18 IV over 1 minute and then undergo positron emission tomography (PET) scanning of the brain over 2 hours.

After completion of the PET scan, patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas

NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors

University of Washington

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies	NCT01243359	Clear Cell Rena... Recurrent Renal... Stage I Renal C... Stage II Renal ... Stage III Renal... Stage IV Renal ... Unspecified Adu...	sunitinib malat... bevacizumab pharmacological... laboratory biom... fluorine F 18 f... positron emissi... computed tomogr...	18 Years -	National Cancer Institute (NCI)
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer	NCT00575393	Lung Cancer	gold sodium thi... gene expression... fluorine F 18 f... mass spectromet... pharmacological...	18 Years - 120 Years	Mayo Clinic
Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer	NCT00575393	Lung Cancer	gold sodium thi... gene expression... fluorine F 18 f... mass spectromet... pharmacological...	18 Years - 120 Years	Mayo Clinic
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas	NCT00276770	Brain and Centr...	fluorine F 18 f... positron emissi...	18 Years - 120 Years	University of Washington
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas	NCT00276770	Brain and Centr...	fluorine F 18 f... positron emissi...	18 Years - 120 Years	University of Washington

Spots Global Cancer Trial Database for fluorine f 18 fluorothymidine