CancerPhase 2NCT00127517
Palliative Care Study in Patients With Advanced Cancer
A Phase 2 study testing peptide-nucleic acid solution AVR118 in people with Cancer, run by Advanced Viral Research Corp at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- peptide-nucleic acid solution AVR118
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Mar 2005to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- · Histologically confirmed malignancy (excluding central nervous
- system malignancy)
- · Not a candidate for, or refuses, curative anti-neoplastic therapy.
- · Between the ages of 18 and 80.
- · Symptoms of advanced cancer (loss of appetite, fatigue, weakness,
- malaise) that are not attributed to anemia, concomitant illnesses, or
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- obstruction or loss of organ function.
- · Karnofsky performance status of ³40%, _<_ 80%.
- · Normal cognition, interpreted as a Mini-Mental State Score of at
- least 20.
- · Life expectancy of >4 months.
- · Decrease in weight of at least 5% over the preceding 6 months, with
- no weight gain over the most recent 30 days
- · Pretreatment laboratory data within 7 days of enrollment (if
- screening labs are done within 3 days of Day 1, they need not be
- repeated on Day 1).
- ¨ Hemoglobin >8.5 g/dL on no, or on stable doses (hematocrit stable
- within 1 gram and dose stable for one month) of Epogen or similar
- medication.
- ¨ Absolute neutrophil count (ANC) ³1,500/mm^3 .
- ¨ Platelets ³50,000/mm^3 .
- ¨ Total bilirubin £1.5 the upper limit of normal (ULN).
- ¨ ALT and AST £2.5 times the ULN, or, if the patient has liver
- metastases, £5 times the ULN.
- ¨ Creatinine £1.5 mg/dL.
- ¨ Fasting blood sugar -<1.2 x ULN
- ¨ Normal T3, T4, TSH
- · 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, or to have an
- assistant who can administer the study medication according to the
- protocol.
- · 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.
- · If on an antidepressant, the dose must have been stabilized for at
- least 60 days
Who cannot join
- · Received immunotherapy, radiation therapy or experimental therapy
- within three weeks.
- · Receiving chemotherapy other than third-line, single agent therapy;
- permitted third-line, single agent dose must be stable for at least
- one month.
- · Diabetes requiring insulin or oral hypoglycemic agents.
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- · Mechanical reason to be unable to eat, or is reasonably expected to
- develop an obstruction during the next eight weeks
- · Myocardial infarction within six months of enrollment.
- · Uncontrolled brain metastases or central nervous system disease.
- · Major surgery within four weeks of enrollment.
- · Severe allergies to milk or milk products.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Queens Medical Associates
Fresh Meadows, New York, 11365
Jacobi Medical Center
The Bronx, New York, 10461
Medical Center of Vincennes
Vincennes, Indiana, 47591
About this study
Official title: A Phase II Double Blind, Placebo Controlled, Randomized, > Multicenter Study With AVR118 Solution in Patients With Advanced > Malignancies Who Are Not Candidates for Curative Chemotherapy.
The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some patients receive AVR118, and others receive placebo (an injection expected to have no benefits). After three weeks, all patients will be offered the opportunity to take injections of AVR118.
Read the detailed description
Advanced cancers are usually debilitating. There are few treatments available for symptoms of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood. A Phase II, double blind study comparing treatment with AVR118 to placebo, followed by an open label phase treating all patients with AVR118, will enable the Sponsor to gather data on safety and efficacy of AVR118 in this patient population. Patients aged 18-80 with advanced cancers (excluding central nervous system [CNS] cancers) who are not receiving chemotherapy, or who are receiving single agent, third line (or beyond) chemotherapy, may be eligible to participate.
- Conditions
- Cancer
- Being tested
- peptide-nucleic acid solution AVR118
- Keywords
- Oncology, Palliative Care, Advanced Cancer, Palliative Cancer Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peptide-nucleic acid solution AVR118Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startMar 2005
- Study completionAug 2006
Why it stopped: Company shifted focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Advanced Viral Research Corp
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127517
- Sponsor's protocol ID
- AVR118 04-002
- Status last verified
- Jun 2011
- First submitted
- 5 Aug 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double Blind, Placebo Controlled, Randomized, > Multicenter Study With AVR118 Solution in Patients With Advanced > Malignancies Who Are Not Candidates for Curative Chemotherapy.
- ClinicalTrials.gov ID
- NCT00127517
- Acronym / sponsor ID
- AVR118 04-002
- Conditions
- Cancer
- Keywords
- Oncology, Palliative Care, Advanced Cancer, Palliative Cancer Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company shifted focus
- Lead sponsor
- Advanced Viral Research CorpIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some patients receive AVR118, and others receive placebo (an injection expected to have no benefits). After three weeks, all patients will be offered the opportunity to take injections of AVR118.
Detailed description
Advanced cancers are usually debilitating. There are few treatments available for symptoms of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood. A Phase II, double blind study comparing treatment with AVR118 to placebo, followed by an open label phase treating all patients with AVR118, will enable the Sponsor to gather data on safety and efficacy of AVR118 in this patient population. Patients aged 18-80 with advanced cancers (excluding central nervous system [CNS] cancers) who are not receiving chemotherapy, or who are receiving single agent, third line (or beyond) chemotherapy, may be eligible to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- · Histologically confirmed malignancy (excluding central nervous
- system malignancy)
- · Not a candidate for, or refuses, curative anti-neoplastic therapy.
- · Between the ages of 18 and 80.
- · Symptoms of advanced cancer (loss of appetite, fatigue, weakness,
Key exclusion criteria (12 listed)
- · Received immunotherapy, radiation therapy or experimental therapy
- within three weeks.
- · Receiving chemotherapy other than third-line, single agent therapy;
- permitted third-line, single agent dose must be stable for at least
- one month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peptide-nucleic acid solution AVR118 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Company shifted focus). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peptide-nucleic acid solution AVR118 in people with Cancer, run by Advanced Viral Research Corp at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company shifted focus). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.