Neoplasms

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Sarcoma

Recurrence

Brain Neoplasms

Central Nervous System Neoplasms

Meningioma

Nervous System Neoplasms

Solitary Fibrous Tumors

Hemangiopericytoma

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Soft Tissue Sarcoma

Brain Tumor, Adult

All Drugs and Chemicals

Vatalanib

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.

Patients who are responding may remain on study treatment for 12 months.

vatalanib

Jeffrey J. Raizer, MD

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.

OBJECTIVES:

Primary

* Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.

Secondary

* Determine the 6-month progression-free survival of these patients.
* Describe the response rate and overall survival of these patients.
* Determine the safety of vatalanib in these patients.
* Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
* Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.

OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Vatalanib in Treating Patients With Recurrent or Progressive Meningioma

A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas

Data concerning certain genes that cause tumors to grow new blood vessels will be examined by MRI scan with MR Perfusion done before treatment and then every 2 months while on study treatment

FACT BR questionnaire will be used to measure quality of life at baseline and then every time an MRI scan is performed while on study treatment

Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.

Efficacy will be assessed by MRI scan and neurological exam upon study entry, every 2 weeks for 2 months, then every 8 weeks while on treatment

Overall Response Rate (ORR) will be as assessed by MRI scan every 2 months while on study treatment and follow-up for up to 1 year after discontinuation of study treatment. The RR is the best response recorded from the start of the treatment until disease progression (PD) where the following definitions apply.

Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions.

Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.

Stable/No Response: Does not qualify for CR, PR, or PD Progressive disease (PD):25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) worsening of evaluable disease, new lesions, clinical worsening OR failure to return for evaluation due to death/deteriorating condition

Correlation of response rates with the expression of certain types of genes will be assessed by examining tissue samples taken from previous surgery and testing for certain genes

Safety of vatalanib will be assessed using National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE) 3.0 and graded using the following:

Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Fatal

Overall Survival will be measured from the first treatment on study until death of any cause.

Novartis

Northwestern University

Jeffrey Raizer, MD

Patients were assessed for adverse events every 2 weeks for the first 2 months, then every 4 weeks (monthly) while on treatment and up to 30 days after the final dose of study drug.

Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.

Patients who are responding may remain on study treatment for 12 months.

vatalanib

21-30

31-40

41-50

51-60

61-70 years

71-80

81-90

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.

Data not collected. Statistical design of study was based on participation of patients with WHO grade I meningioma. Most patients enrolled in the study were WHO grade II and WHO grade III.

Determine Efficacy (Radiographic and Clinical Improvement)

SD on MRI but clinical decline

Best Overall Response Rate (ORR)

To Correlate the Response Rates With Expression of Certain Types of Genes

Dehydration

Deep vein thrombosis

Fatigue

Gastrointestinal

Hypertension

Hyponatremia

Leukopenia

Pain

Rash

Transaminase

Weight loss

Toxicities determined to be either grade 3 or grade 4 and at least possibly related to study drug are reported here.

Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas

Number of Months Patients Survive After Being Treatment on the Study.

Number of patients with WHO grade II or WHO grade III meningioma.

Overall Survival (OS)

Develop Data Concerning Certain Genes That Cause Tumors to Grow New Blood Vessels

To Use the FACT BR Questionnaire to Measure Quality of Life

Began Treatment

Completed Treatment

Skin and Connective Tissue Diseases

Glioma

Astrocytoma

Oligodendroglioma

Pinealoma

Ependymoma

Neoplasms, Fibrous Tissue

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Brain Diseases

Central Nervous System Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Pineocytoma

Diffuse Astrocytoma

Neuroepithelioma

Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

proton beam radiation therapy

quality-of-life assessment

questionnaire administration

Robert Lustig

RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the best way to give proton beam radiation therapy and to see how well it works in treating patients with low grade gliomas.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of proton beam radiation therapy in patients with low grade gliomas. (Phase I)

SECONDARY OBJECTIVES:

I. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) II. To assess acute side effects from irradiation using proton beam therapy in place of conventional photon beam therapy for the treatment of low grade gliomas. (Phase II) III. To compare the dose distribution to tumor and surrounding normal structures using DVH's (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. (Phase II) IV. To monitor the rates of local control, overall and disease specific survival using proton radiotherapy. (Phase II) V. To evaluate the time to progression of low grade gliomas treated with protons. (Phase II) VI. To evaluate the incidence and severity of fatigue in low grade glioma treated with protons. (Phase II) VII. To evaluate the effect of proton beam radiation on neurocognitive outcome in patients with low grade glioma. (Phase II) VIII. To evaluate the quality of life in patients treated for low grade glioma. (Phase II)

OUTLINE: Patients undergo proton beam radiation therapy for 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas

Proton Radiation for Low Grade Gliomas

Abramson Cancer Center at Penn Medicine

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Glioblastoma

Neoplasm Metastasis

Pituitary Diseases

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Pituitary Neoplasms

Craniopharyngioma

Adamantinoma

Gliosarcoma

Choroid Plexus Neoplasms

Glioma, Subependymal

Germ Cells Tumors

Acute Graft Versus Host Disease

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Pilocytic Astrocytoma

Anaplastic Ependymoma

Embryonal Tumor With Multilayered Rosettes

Subependymoma

Myxopapillary Ependymoma

Hormones

Patients complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

Questionnaire

John Suh, MD

RATIONALE: Learning about the side effects of stereotactic radiosurgery in patients with brain tumors or other brain disorders may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This clinical trial is studying the acute side effects in patients who are undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

OBJECTIVES:

* Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.
* Determine the time frame for development and resolution of these complications in these patients.
* Determine the severity of these complications in these patients.

OUTLINE: Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.

Determine the incidence and types of acute complications in patients undergoing stereotactic radiosurgery for brain tumors or other brain disorders.

Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders

Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery

Patients undergo stereotactic radiosurgery. Patients also complete questionnaires about the side effects they experience from radiosurgery. The questionnaires are completed at baseline and at 1 week, 1 month, and 2 months after radiosurgery.

Case Comprehensive Cancer Center

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphosarcoma

Primary Central Nervous System Lymphoma

Subependymal Giant Cell Astrocytoma

Antineoplastic Agents

Anticonvulsants

Temozolomide

Bortezomib

Antineoplastic Agents, Alkylating

Alkylating Agents

GROUP A: Patients receive oral temozolomide once a day on days 1-5 and bortezomib IV on days 2, 5, 9, and 12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive temozolomide and bortezomib as in group A. Cohorts of patients in both groups receive escalating doses of both study drugs until the maximum tolerated doses are determined. All patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for bortezomib concentration (groups A and B) and trough levels of anticonvulsants (group A only).

bortezomib

temozolomide

pharmacological study

Jana Portnow, MD

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with temozolomide may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with temozolomide in treating patients with brain tumors or other solid tumors that have not responded to treatment.

OBJECTIVES:

Primary

* To determine the dose-limiting toxicities and maximum tolerated doses of bortezomib and temozolomide in patients with recurrent high-grade gliomas, recurrent metastatic brain tumors, or other refractory solid tumors.

Secondary

* To evaluate the pharmacokinetics of bortezomib in patients taking hepatic enzyme-inducing anticonvulsants (Group A) and in those who are not (Group B).
* To describe the proportion of study patients treated with bortezomib and temozolomide who obtain a confirmed complete response or partial response.
* To report the percentage of patients with 6-month progression-free survival.

OUTLINE: Patients are stratified according to concurrent hepatic enzyme-inducing anticonvulsants (HEIAs) (Group A) versus concurrent anticonvulsant drugs that cause modest or no induction of hepatic metabolic enzymes OR no anticonvulsant drugs (Group B).

* Group A: Patients receive oral temozolomide once a day on days 1-5 and bortezomib IV on days 2, 5, 9, and 12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Group B: Patients receive temozolomide and bortezomib as in group A. Cohorts of patients in both groups receive escalating doses of both study drugs until the maximum tolerated doses are determined.

All patients undergo blood sample collection periodically for pharmacokinetic studies. Samples are analyzed for bortezomib concentration (groups A and B) and trough levels of anticonvulsants (group A only).

Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment

A Phase I Study of Bortezomib and Temozolomide in Patients With Refractory Solid Tumors

National Cancer Institute (NCI)

City of Hope Medical Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma	NCT00348790	Brain and Centr... Sarcoma	vatalanib	18 Years -	Northwestern University
Proton Beam Radiation Therapy in Treating Patients With Low Grade Gliomas	NCT01024907	Adult Brain Tum... Adult Brain Ste... Adult Diffuse A... Adult Ependymom... Adult Grade II ... Adult Melanocyt... Adult Meningeal... Adult Mixed Gli... Adult Oligodend... Adult Pineal Gl... Adult Pineocyto... Recurrent Adult...	proton beam rad... quality-of-life... questionnaire a...	18 Years -	Abramson Cancer Center at Penn Medicine
Vatalanib in Treating Patients With Recurrent or Progressive Meningioma	NCT00348790	Brain and Centr... Sarcoma	vatalanib	18 Years -	Northwestern University
Acute Side Effects in Patients Who Are Undergoing Stereotactic Radiosurgery for Brain Tumors or Other Brain Disorders	NCT00255671	Brain and Centr... Metastatic Canc... Radiation Toxic...	Questionnaire	18 Years -	Case Comprehensive Cancer Center
Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment	NCT00544284	Brain and Centr... Lymphoma Metastatic Canc... Unspecified Adu...	bortezomib temozolomide pharmacological...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for adult melanocytic lesion