Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Condition: Cancer
MeSH terms: Weight Loss
Intervention: cyproheptadine hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Cyproheptadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 2 Years
Maximum age: 21 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  ≥ 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)

        EXCLUSION CRITERIA:

          -  ≥ 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.