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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by McGill University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00765466
First received: October 2, 2008
Last updated: October 21, 2008
Last verified: September 2008
  Purpose

This is an open label, Phase II, multi-center study designed to evaluate the effect of AVR118 when administered to patients with systemic symptoms related to recurrent or metastatic cancers who may or may not be undergoing anti-cancer treatment. During the initial, induction treatment phase of the study, AVR118, 4.0 mL, will be given subcutaneously each day for 28 days. Patients who respond to the trial period dosing will be eligible to continue on AVR118 if they and their physicians believe it would be beneficial, and if no safety concerns are raised.


Condition Intervention Phase
Cancer
Drug: AVR118
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Karnofsky Performance Status Disease-related symptoms: ESAS and PG-SGA Anorexia Weight Lean Body Mass, Triceps skin fold, and grip strength [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AVR118
    daily doses of 4.0 mL AVR118 subcutaneously
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765466

Contacts
Contact: Martin Chasen 514-934-1934 ext 35997 martin.chasen@mcgill.ca

Locations
Canada, Quebec
McGill University Clinical Research Program Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Mirabel de Diego    (914) 376 7383    maribeld@adviral.com]   
Principal Investigator: Martin Chasen         
Sponsors and Collaborators
McGill University
Investigators
Study Director: Maribel de Diego, Ph.D. Advances Viral Research Corporation
  More Information

No publications provided

Responsible Party: Dr. Martin Chasen, McGill University
ClinicalTrials.gov Identifier: NCT00765466     History of Changes
Other Study ID Numbers: McG 0710
Study First Received: October 2, 2008
Last Updated: October 21, 2008
Health Authority: Canada: Health Canada
CANADA: Scimega Research
CANADA: Advanced Viral Research Corporation

Keywords provided by McGill University:
Explore the effect of AVR118 4.0 mL, given subcutaneously on appetite

Additional relevant MeSH terms:
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014