NCT01206335

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.3 years

First QC Date

September 20, 2010

Last Update Submit

November 26, 2012

Conditions

AnorexiaCancer Cachexia

Keywords

Cancer CachexiaAnorexiaAdvanced MalignanciesWeight LossFatigueKarnofskyC-Reactive ProteinSimmonds Functional Assessment

Outcome Measures

Primary Outcomes (1)

  • Alleviation of multiple cachexia symptoms

    Functional Status/Quality of Life as assessed by Simmonds Functional Assessment (SFA); Appetite and early satiety as assesed by patetient-generated subjective global assessment (PG-SGA), Edmonton Symptom assessment Scale (ESAS) and dyspepsia symptom severity index (DSSI); weight gain; increase in lean body mass.

    Four weeks

Secondary Outcomes (1)

  • Impact on inflammatory markers and hormonal milieu

    4 weeks

Study Arms (1)

OHR/AVR118

EXPERIMENTAL

Experimental Drug

Drug: OHR/AVR118

Interventions

OHR/AVR118DRUG

OHR/AVR118 given subcutaneously at 4mL per day

Also known as: AVR118
OHR/AVR118

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

AnorexiaWeight LossFatigue

Interventions

EOM613

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBody Weight

Study Officials

  • Martin Chasen, MBChB

    Ottawa Hospital Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

CA(1)