Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether patients with advanced cancers who receive OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a previous study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain, improved mood; and decreased fatigue.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohr Pharmaceutical Inc.

Criteria

Inclusion Criteria:

• 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 ULN.

• 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 study

Exclusion Criteria:

• 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.