Clinical trial NCT00066248 (phase 2, status: completed)
Conditions: brain tumor, central nervous system tumors, cachexia, leukemia, lymphoma, myelodysplastic syndromes, myelodysplastic/myeloproliferative diseases, unspecified childhood solid tumor, protocol specific
ICD codes: C71.7, C71.9, C79.31, D33.0, D33.1, D33.2, D49.6, C72.9, D33.9, D43.9, D33.7, D43.8, R64, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, D46.9, D46.C, D46.Z, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: cyproheptadine hydrochloride, megestrol acetate
SMILES: CN1CCC(CC1)=C1C2=CC=CC=C2C=CC2=CC=CC=C12, [H][C@@]12CC[C@](OC(C)=O)(C(C)=O)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])C=C(C)C2=CC(=O)CC[C@]12C
Eligibility criteria:

        INCLUSION CRITERIA:

          -  Any cachectic patient with weight loss presumed secondary to cancer or cancer related
             therapy is eligible. Cachexia is defined as having one or more of the following:

          -  documented history of weight loss > 5%

          -  drop in growth rate two or more percentile ranks on standard growth charts,

          -  weight for height less than the tenth percentile.

          -  Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.

          -  Patients who are receiving active or palliative therapy are eligible.

          -  If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy)
             within 8 weeks of study registration, they are also eligible.

          -  Patients must be ≥ 2 years and < 21 years of age at the time of admission to this
             study.

          -  Patients must have a predicted life expectancy of at least eight weeks.

        EXCLUSION CRITERIA:

          -  Patients who are currently taking or who have taken Periactin and/or Megace during the
             past three weeks are not eligible.

          -  Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy.
             (Intermittent steroid use is permitted IF you anticipate it will not be administered
             for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid
             use in 4-week intervals through the 8-week period during which study agent may be
             administered (4 weeks for Periactin and potentially 4 weeks for Megace.

          -  Patients who have received parenteral nutrition or tube feedings within 1 week of
             starting this protocol or patients who are expected to require parenteral nutrition or
             tube feedings during the 4-week course of this study.

          -  Patients taking dronabinol (Marinol) or other appetite-stimulating medications during
             the past three weeks or patients expected to be prescribed appetite-stimulating
             medications during the 4-week course of this study.

          -  Patients with hormone sensitive tumors specifically meningiomas, breast cancer,
             ovarian cancer, and endometrial carcinoma.31, 32

          -  Children with neurofibromatosis, type I or II, are at risk for the development of
             meningiomas and are thus excluded from this study.32

          -  Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or
             genitourinary (GU) obstruction.

          -  Patients with recurrent and/or persistent hypertension, defined as blood pressure
             values >20% above normal.

          -  Patients with thromboembolic disease, congestive heart failure, or peripheral edema.

          -  Patients who are pregnant.