Status:
TERMINATED
A Phase II Open Label, Multi-Center Study With AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
Lead Sponsor:
McGill University
Conditions:
Cancer
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00765466
Start Date
October 1 2007
End Date
May 1 2010
Last Update
March 14 2019
Active Locations (1)
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1
McGill University Clinical Research Program
Montreal, Quebec, Canada, H2W 1S6