A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
- Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
- Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is
permitted except for neo-adjuvant or adjuvant programs.
- Between the ages of 18-85.
- Symptoms of recurrent or metastatic cancer in which anorexia is a predominant
symptom, not necessarily associated with cachexia, and are not attributed to anemia,
concomitant illnesses, or obstruction or loss of organ function.
- Karnofsky performance status of 40%
- Palliative Prognostic Score (PaP) of less than 6
- Patient is expected to be able to remain on a study protocol for two months.
- Pretreatment laboratory data within 7 days of enrollment:
- Hemoglobin >8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose
stable for one month) of erythropoietin or similar medication.
- Absolute neutrophil count (ANC) 1,500/mm3.
- Platelets 50,000/mm3.
- Total bilirubin 2.0
- ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the
- Creatinine 1.5 mg/dL.
- Normal TSH
- Testosterone levels determined.
- Voluntary written informed consent before performance of any study-related procedure
that is not part of normal medical care.
- Ability to self-administer subcutaneous medication if an assistant or nurse is not
available, and to keep a compliance journal documenting injections at home.
- If on an antidepressant, the dose must have been stabilized for at least 30 days.
- Female patient is post-menopausal, surgically sterilized, or willing to use
acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the
duration of the study.
- Male patient agrees to use an acceptable barrier method for contraception during the
- Patient has uncontrolled brain metastases or central nervous system disease.
- Patient has mechanical, non-reversible reason for not being able to eat, or have a
potential for developing malignant bowel obstruction during the course of the
induction phase of treatment, or patients requiring a PEG for obstruction.
- Patient has had any major surgery within four weeks of enrollment.
- Patient has an uncontrolled concomitant illness including, but not limited to,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, or cardiac arrhythmia.
- In the Investigator's opinion, potentially interfere with the completion of treatment
according to this protocol.
- Female patient is pregnant or breast-feeding.