Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Eye Diseases

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Renal Cell

Liver Neoplasms

Glioma

Retinoblastoma

Sarcoma

Teratoma

Brain Neoplasms

Wilms Tumor

Central Nervous System Neoplasms

Medulloblastoma

Neuroblastoma

Sarcoma, Ewing

Testicular Neoplasms

Kidney Neoplasms

Nervous System Neoplasms

Astrocytoma

Ependymoma

Rhabdomyosarcoma

Desmoplastic Small Round Cell Tumor

Hepatoblastoma

Chordoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neuroectodermal Tumors, Primitive, Peripheral

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Soft Tissue Sarcoma

Germ Cells Tumors

Wilms' Tumor

Ewing Sarcoma

Brain Tumor, Adult

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Neuroepithelioma

Malignant Germ Cell Tumor

Extragonadal Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Melphalan

Lenograstim

Busulfan

Liver Extracts

Thiotepa

Amifostine

Adjuvants, Immunologic

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Protective Agents

Radiation-Protective Agents

Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.

amifostine trihydrate

Patients receive oral busulfan every 6 hours on days -8 to -6.

busulfan

All patients receive filgrastim (G-CSF) IV for 1 week.

filgrastim

melphalan intravenous (IV) over 30 minutes on days -5 and -4

melphalan

thiotepa intravenous (IV) over 2 hours on days -3 and -2.

thiotepa

peripheral blood stem cell transplantation (PBSC)

John P. Perentesis, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.

OBJECTIVES:

* Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors.
* Determine response or time to disease progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to age (1 to 18 vs 19 to 45 years).

All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration, patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy.

Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. PBSC are reinfused on day 0.

Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC transplantation.

PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

A Phase I Study of the Chemoprotectant Amifostine With Autologous Stem Cell Transplantation for High Risk or Relapsed Pediatric Solid Tumors and Brain Tumors

Masonic Cancer Center, University of Minnesota

John Perentesis, MD

Blood and Lymph Conditions

Immune System Diseases

Nutritional and Metabolic Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Glioblastoma

Meningioma

Oligodendroglioma

Body Weight

Nausea

Vomiting

Osteosarcoma

Liposarcoma

Lymphoma

Weight Loss

Body Weight Changes

Carcinosarcoma

Mixed Tumor, Mullerian

Sarcoma, Endometrial Stromal

Chondrosarcoma

Fibrosarcoma

Wasting Syndrome

Cachexia

Hemangiosarcoma

Leiomyosarcoma

Sarcoma, Synovial

Neurofibrosarcoma

Lymphoma, Large-Cell, Anaplastic

Leukemia, Myelomonocytic, Acute

Gliosarcoma

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

Lymphosarcoma

Acute Graft Versus Host Disease

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Endometrial Stromal Sarcoma

Brain Tumor, Childhood

Anaplastic Astrocytoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Epithelioid Sarcoma

Anaplastic Large Cell Lymphoma

Uterine Sarcoma

Nonseminomatous Germ Cell Tumor

Anaplastic Oligodendroglioma

Optic Pathway Glioma

Alveolar Soft Part Sarcoma

Diffuse Astrocytoma

Childhood Brain Stem Glioma

Supratentorial Primitive Neuroectodermal Tumor

Pilocytic Astrocytoma

Uterine Carcinosarcoma

Anti-Allergic Agents

Dermatologic Agents

Gastrointestinal Agents

Cyproheptadine

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

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

National Cancer Institute (NCI)

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

Sex: Female, Male

United States

Region of Enrollment

Angelina Fink, Research Base Administrator

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors	NCT00003926	Brain and Centr... Childhood Germ ... Chordoma Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma	amifostine trih... busulfan filgrastim melphalan thiotepa peripheral bloo...	1 Year - 45 Years	Masonic Cancer Center, University of Minnesota
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer	NCT01132547	Cancer	cyproheptadine ... placebo	2 Years - 21 Years	University of South Florida
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma	NCT04901702	Recurrent Solid... Recurrent Ewing... Recurrent Hepat... Recurrent Malig... Recurrent Malig... Recurrent Neuro... Recurrent Osteo... Recurrent Perip... Recurrent Rhabd... Recurrent Rhabd... Recurrent Soft ... Recurrent Wilms... Refractory Ewin... Refractory Hepa... Refractory Mali... Refractory Mali... Refractory Neur... Refractory Oste... Refractory Peri... Refractory Rhab... Refractory Rhab... Refractory Soft...	Onivyde Talazoparib Temozolomide	12 Months - 30 Years	St. Jude Children's Research Hospital

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