Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

NCT01132547 | Terminated Phase 3 Results DMC

• 3 other identifiers: SCUSF 0703SCUSF-07035U10CA081920-11
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Cancer

Keywords

cachexia; weight changes; nausea and vomiting; alveolar childhood rhabdomyosarcoma; anaplastic osteosarcoma; childhood alveolar soft-part sarcoma; childhood angiosarcoma; childhood epithelioid sarcoma; childhood fibrosarcoma; childhood gliosarcoma; childhood leiomyosarcoma; childhood liposarcoma; childhood neurofibrosarcoma; childhood synovial sarcoma; chondrosarcoma; chondrosarcomatous osteosarcoma; clear cell sarcoma of the kidney; embryonal childhood rhabdomyosarcoma; embryonal-botryoid childhood rhabdomyosarcoma; endometrial stromal sarcoma; extraosseous Ewing sarcoma; peripheral primitive neuroectodermal tumor; fibrosarcomatous osteosarcoma; localized Ewing sarcoma; localized osteosarcoma; mast cell sarcoma; metastatic childhood soft tissue sarcoma; metastatic Ewing sarcoma; metastatic osteosarcoma; mixed childhood rhabdomyosarcoma; mixed osteosarcoma; nonmetastatic childhood soft tissue sarcoma; osteoblastic osteosarcoma; ovarian carcinosarcoma; ovarian sarcoma; pleomorphic childhood rhabdomyosarcoma; previously treated childhood rhabdomyosarcoma; previously untreated childhood rhabdomyosarcoma; recurrent adult soft tissue sarcoma; recurrent childhood gliosarcoma; recurrent childhood rhabdomyosarcoma; recurrent childhood soft tissue sarcoma; recurrent Ewing sarcoma; recurrent osteosarcoma; recurrent uterine sarcoma; small intestine leiomyosarcoma; stage I uterine sarcoma; stage II uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; telangiectatic osteosarcoma; untreated childhood gliosarcoma; uterine carcinosarcoma; uterine leiomyosarcoma; localized resectable neuroblastoma; localized unresectable neuroblastoma; recurrent neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma; recurrent Wilms tumor; childhood kidney tumors; stage III Wilms tumor; stage IV Wilms tumor; childhood hepatoblastoma; childhood extracranial germ cell tumor; childhood extragonadal germ cell tumor; childhood gonadal germ cell tumor; childhood malignant ovarian germ cell tumor; childhood malignant testicular germ cell tumor; recurrent childhood malignant germ cell tumor; recurrent extragonadal germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent malignant testicular germ cell tumor; recurrent ovarian germ cell tumor; stage III extragonadal non-seminomatous germ cell tumor; stage III malignant testicular germ cell tumor; stage IIIA ovarian germ cell tumor; stage IIIB ovarian germ cell tumor; stage IIIC ovarian germ cell tumor; stage IV extragonadal non-seminomatous germ cell tumor; stage IV ovarian germ cell tumor; recurrent childhood medulloblastoma; untreated childhood medulloblastoma; childhood ependymoblastoma; childhood infratentorial ependymoma; newly diagnosed childhood ependymoma; recurrent childhood ependymoma; recurrent childhood subependymal giant cell astrocytoma; untreated childhood subependymal giant cell astrocytoma; peripheral primitive neuroectodermal tumor of the kidney; childhood supratentorial primitive neuroectodermal tumor; recurrent childhood brain stem glioma; recurrent childhood brain tumor; untreated childhood brain stem glioma; recurrent childhood anaplastic astrocytoma; recurrent childhood anaplastic oligoastrocytoma; recurrent childhood anaplastic oligodendroglioma; stage I childhood anaplastic large cell lymphoma; stage II childhood anaplastic large cell lymphoma; stage III childhood anaplastic large cell lymphoma; stage IV childhood anaplastic large cell lymphoma; untreated childhood anaplastic astrocytoma; untreated childhood anaplastic oligoastrocytoma; untreated childhood anaplastic oligodendroglioma; childhood high-grade cerebellar astrocytoma; childhood low-grade cerebellar astrocytoma; recurrent childhood astrocytoma; other tumor of glial origin; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood diffuse astrocytoma; recurrent childhood fibrillary astrocytoma; recurrent childhood gemistocytic astrocytoma; recurrent childhood oligoastrocytoma; recurrent childhood pilocytic astrocytoma; recurrent childhood pilomyxoid astrocytoma; recurrent childhood pleomorphic xanthoastrocytoma; recurrent childhood protoplasmic astrocytoma; untreated childhood cerebellar astrocytoma; untreated childhood cerebral astrocytoma; untreated childhood diffuse astrocytoma; untreated childhood fibrillary astrocytoma; untreated childhood gemistocytic astrocytoma; untreated childhood oligoastrocytoma; untreated childhood pilocytic astrocytoma; untreated childhood pilomyxoid astrocytoma; untreated childhood pleomorphic xanthoastrocytoma; untreated childhood protoplasmic astrocytoma; recurrent childhood gliomatosis cerebri; recurrent childhood oligodendroglioma; recurrent childhood visual pathway; hypothalamic glioma; recurrent childhood visual pathway glioma; untreated childhood gliomatosis cerebri; untreated childhood oligodendroglioma; untreated childhood visual pathway; untreated childhood visual pathway glioma; recurrent childhood giant cell glioblastoma; recurrent childhood glioblastoma; untreated childhood giant cell glioblastoma; untreated childhood glioblastoma; childhood choroid plexus tumor; childhood grade I meningioma; childhood grade II meningioma; childhood grade III meningioma; minimally differentiated myeloid leukemia (M0); myeloblastic leukemia with maturation (M2); myeloblastic leukemia without maturation (M1); childhood acute myelomonocytic leukemia (M4); childhood acute promyelocytic leukemia (M3); recurrent childhood acute myeloid leukemia; untreated childhood acute myeloid leukemia; other myeloid malignancies; childhood acute monoblastic leukemia (M5a); childhood acute monocytic leukemia (M5b); childhood acute erythroleukemia (M6); childhood acute megakaryocytic leukemia (M7); unspecified childhood solid tumor

Outcome Measures

Primary Outcomes (2)

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

  8 weeks

• Severity of Weight Loss

  Change from Baseline in Weight Z score

  Baseline and 8 weeks

Secondary Outcomes (1)

• Pattern of Weight in the Study Population

  Baseline and 8 weeks

Study Arms (2)

Arm I cyproheptadine hydrochloride

EXPERIMENTAL

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

Drug: cyproheptadine hydrochloride

Arm II placebo

PLACEBO COMPARATOR

Patients receive an oral placebo twice daily for 8 weeks.

Other: placebo

Interventions

cyproheptadine hydrochloride DRUG

Given orally

Also known as: cyproheptadine HCl

Arm I cyproheptadine hydrochloride

placebo OTHER

Given orally

Arm II placebo

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ≥ 2 years and ≤ 21 years of age at the time of study entry
• Scheduled to receive chemotherapy for:
• Newly diagnosed:
• Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
• Intermediate or high-risk neuroblastoma
• Wilms' tumor (Stage III/IV)
• Hepatoblastoma (Stage III/IV)
• Germ cell tumors (Stage III/IV)
• Brain tumors, including medulloblastoma, PNET and ependymomas
• AML
• Relapsed/recurrent disease (any patient)
• Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)

You may not qualify if:

• ≥ 29 days after starting chemotherapy
• Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
• Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
• History of anorexia nervosa or bulimia
• Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
• Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
• Children receiving steroids for \>7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study
• Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
• Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction
• Allergy to cyproheptadine HCl
• Females of childbearing age must not be pregnant.
• Female patients who are lactating must agree to stop breast-feeding.

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (14)

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

A.I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Southwest Florida at Lee Memorial

Fort Myers, Florida, 33908, United States

Location

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, 32207-8482, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Nemours Children's Hospital Pensacola

Pensacola, Florida, 32504, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78207, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Neoplasms; Cachexia; Body Weight Changes; Nausea; Vomiting; Hemangiosarcoma; Sarcoma; Fibrosarcoma; Liposarcoma; Chondrosarcoma; Sarcoma, Endometrial Stromal; Neuroectodermal Tumors, Primitive, Peripheral; Mast-Cell Sarcoma; Sarcoma, Ewing; Osteosarcoma; Bone Neoplasms; Neuroblastoma; Wilms Tumor; Hepatoblastoma; Ovarian Germ Cell Cancer; Testicular Neoplasms; Medulloblastoma; Familial ependymoma; Astrocytoma; Oligodendroglioma; Lymphoma, Large-Cell, Anaplastic; Neoplasms, Neuroepithelial; Optic Nerve Glioma; Glioblastoma; Choroid Plexus Neoplasms

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Mastocytosis; Mast Cell Activation Disorders; Immune System Diseases; Neoplasms, Bone Tissue; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Kidney Neoplasms; Urologic Neoplasms; Neoplastic Syndromes, Hereditary; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Genital Diseases, Male; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Glioma; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Nervous System Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Eye Diseases; Cerebral Ventricle Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Angelina Fink, Research Base Administrator
• Organization: SunCoast CCOP Research Base at the University of South Florida

angelina.fink@epi.usf.edu

813-396-9245

Study Officials

• Jeffrey P. Krischer, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 2, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

US (14)