Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Eye Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Ependymoma

Gliosarcoma

Optic Nerve Glioma

Neoplasms, Neuroepithelial

Disease Attributes

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Optic Nerve Neoplasms

Peripheral Nervous System Neoplasms

Cranial Nerve Diseases

Optic Nerve Diseases

Brain Tumor, Adult

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Optic Pathway Glioma

Diffuse Astrocytoma

Childhood Brain Stem Glioma

Pilocytic Astrocytoma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Anaplastic Ependymoma

Gliomatosis Cerebri

Subependymal Giant Cell Astrocytoma

Cerebellar Astrocytoma, Childhood

Cerebral Astrocytoma, Childhood

Neuroepithelioma

All Drugs and Chemicals

Cardiotonic Agents

Fluorides

Dihydroxyphenylalanine

Dopamine

Dopamine Agents

Neurotransmitter Agents

Patients receive 18F-fluoro-dihydroxyphenylalanine (18F-FDOPA) intravenously (IV) and then undergo positron emission tomography / computed tomography (PET/CT) or PET/magnetic resonance imaging (PET/MRI) scans 10 to 30 minutes later.

18F-fluoro-dihydroxyphenylalanine

Component of an 18F-FDOPA PET/CT or PET/MRI scan

Positron emission tomography (PET)

Computed tomography (CT)

Magnetic resonance imaging

Erik Mittra, MD, PhD

To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.

This clinical trial compares fluorine F-18 fluoro-dihydroxyphenylalanine (18F-fluorodopa or 18F-FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F-FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.

18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas

18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas

The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.

For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.

National Cancer Institute (NCI)

Erik Mittra

Clinical Assistant Professor

Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.

Diagnostic (FDOPA-PET/CT or PET/MRI)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

This study was underpowered due to low enrollment

Number of Suspicious Lesions Identified by 18F FDOPA PET

Percent Agreement of 18F FDOPA PET With Pathology

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Meningioma

Body Weight

Nausea

Vomiting

Osteosarcoma

Neuroblastoma

Sarcoma

Liposarcoma

Lymphoma

Weight Loss

Body Weight Changes

Wilms Tumor

Medulloblastoma

Sarcoma, Ewing

Carcinosarcoma

Mixed Tumor, Mullerian

Testicular Neoplasms

Sarcoma, Endometrial Stromal

Chondrosarcoma

Fibrosarcoma

Neuroectodermal Tumors, Primitive, Peripheral

Wasting Syndrome

Cachexia

Hemangiosarcoma

Kidney Neoplasms

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Neurofibrosarcoma

Lymphoma, Large-Cell, Anaplastic

Leukemia, Myelomonocytic, Acute

Hepatoblastoma

Sarcoma, Alveolar Soft Part

Sarcoma, Clear Cell

Leukemia, Promyelocytic, Acute

Leukemia, Monocytic, Acute

Choroid Plexus Neoplasms

Leukemia, Erythroblastic, Acute

Leukemia, Megakaryoblastic, Acute

Mast-Cell Sarcoma

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Soft Tissue Sarcoma

Lymphosarcoma

Germ Cells Tumors

Acute Graft Versus Host Disease

Wilms' Tumor

Ewing Sarcoma

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Endometrial Stromal Sarcoma

Brain Tumor, Childhood

Ovarian Germ Cell Tumor

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Epithelioid Sarcoma

Testicular Germ Cell Tumor

Anaplastic Large Cell Lymphoma

Uterine Sarcoma

Nonseminomatous Germ Cell Tumor

Alveolar Soft Part Sarcoma

Malignant Germ Cell Tumor

Supratentorial Primitive Neuroectodermal Tumor

Uterine Carcinosarcoma

Anti-Allergic Agents

Dermatologic Agents

Gastrointestinal Agents

Cyproheptadine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Serotonin

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

Patients receive an oral placebo twice daily for 8 weeks.

cyproheptadine hydrochloride

placebo

Jeffrey P. Krischer, PhD

RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.

OBJECTIVES:

Primary

* To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.

Secondary

* To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
* Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.

OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.

* Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
* Arm II: Patients receive an oral placebo twice daily for 8 weeks.

Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.

Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk

University of South Florida

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally

Arm I Cyproheptadine Hydrochloride

Patients receive an oral placebo twice daily for 8 weeks.

placebo: Given orally

Arm II Placebo

Total

Age, Continuous

Angelina Fink, Research Base Administrator

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline

Severity of Weight Loss

Pattern of Weight in the Study Population

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas	NCT02175745	Adult Anaplasti... Adult Anaplasti... Adult Brain Ste... Adult Diffuse A... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Mixed Gli... Adult Oligodend... Adult Pilocytic... Adult Pineal Gl... Adult Subependy... Childhood High-... Childhood High-... Childhood Low-g... Childhood Low-g... Recurrent Adult... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Recurrent Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child... Untreated Child...	18F-fluoro-dihy... Positron emissi... Computed tomogr... Magnetic resona...	16 Years -	Stanford University
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer	NCT01132547	Cancer	cyproheptadine ... placebo	2 Years - 21 Years	University of South Florida

Spots Global Cancer Trial Database for untreated childhood anaplastic oligoastrocytoma