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A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Phase 2
19 Years
70 Years
Open (Enrolling)

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Trial Information

A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

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

- 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength

Outcome Time Frame:


Safety Issue:


Principal Investigator

Maribel de Diego, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Advances Viral Research Corporation


Canada: Health Canada

Study ID:

McG 0710



Start Date:

October 2007

Completion Date:

December 2011

Related Keywords:

  • Cancer
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