Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00616213
PR104 and G-CSF in Treating Patients With Solid Tumors
A Phase 1 study testing filgrastim, PR104 and F-18-fluoromisonidazole in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 3 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- filgrastim, PR104 and F-18-fluoromisonidazole
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2008to Jun 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- PTT ≤ 1.5 times normal
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- Serum creatinine ≤ 1.5 times ULN
- ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 30 days after completion of study therapy
- Able to read, understand, and provide written informed consent
Who cannot join
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
- Uncontrolled infection or infection requiring a concomitant parenteral antibiotic
- Uncontrolled diabetes
- Congestive heart failure
- Myocardial infarction within the past 6 months
- Chronic renal disease
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- Coagulopathy (excluding prophylactic anticoagulation)
- Known HIV positivity
- Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests
- PRIOR CONCURRENT THERAPY:
- No more than 3 prior myelosuppressive chemotherapy regimens
- Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:
- Minimally myelosuppressive regimens
- Limited courses of myelosuppressive regimens
- More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)
- More than 24 hours since any prior radiotherapy and no likelihood of toxicity from this therapy
- More than 4 weeks since major surgery
- No prior radiotherapy to > 20% of bone marrow
- No prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplantations)
- Prior and concurrent androgen deprivation therapy allowed
- Concurrent systemic steroids allowed, provided the patient has been on a stable dose for at least 2 weeks prior to first dose of PR-104
- No concurrent irradiation therapy (palliative or therapeutic), unless given in the absence of tumor progression
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, 85258-4512
About this study
Official title: A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.
Secondary
- Characterize the safety of this regimen in these patients.
- Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
- Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging.
- Assess for antitumor toxicity in these patients.
- Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter, dose-escalation study of PR-104.
Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to assess tumor hypoxia.
Patients undergo blood sample collection periodically during course 1. Samples are analyzed for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.
After completion of study treatment, patients are followed at 30 days.
- Being tested
- filgrastim, PR104, F-18-fluoromisonidazole
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
Also called Neupogen, G-CSF
filgrastim will be administered at a standard dose and schedule
PR104Drug
Also called PR-104
PR104 is administered intravenously once every 21 days
F-18-fluoromisonidazoleOther
Also called FMISO
F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of PR-104
Measured: 3 weeks (cycle 1)
Secondary outcomes (5)
Safety profile using CTCAE v3 criteria
Dose-limiting toxicity of PR-104
Pharmacokinetics of PR-104 and its alcohol metabolite in blood
Anti-tumor activity
Biomarkers of tumor hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proacta, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616213
- Sponsor's protocol ID
- PR104-1004
- Other IDs
- PROACTA-PR-104-1004
- Status last verified
- May 2011
- First submitted
- 14 Feb 2008
- Last updated
- 1 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00616213
- Acronym / sponsor ID
- PR104-1004
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Proacta, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 Feb 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.
Secondary
- Characterize the safety of this regimen in these patients.
- Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
- Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging.
- Assess for antitumor toxicity in these patients.
- Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.
OUTLINE: This is a multicenter, dose-escalation study of PR-104.
Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to assess tumor hypoxia.
Patients undergo blood sample collection periodically during course 1. Samples are analyzed for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.
After completion of study treatment, patients are followed at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
Key exclusion criteria (22 listed)
- Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:
- Known HIV positivity
- Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests
- No more than 3 prior myelosuppressive chemotherapy regimens
- More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)
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 |
|---|---|---|
| filgrastimAlso: Neupogen, G-CSFfilgrastim will be administered at a standard dose and schedule | Biological | – |
| PR104Also: PR-104PR104 is administered intravenously once every 21 days | Drug | – |
| F-18-fluoromisonidazoleAlso: FMISOF-18-fluoromisonidazole is administered intravenously prior to performance of PET scan | Other | – |
Primary outcome
Maximum tolerated dose of PR-104
Time frame: 3 weeks (cycle 1)
5 secondary outcomes
Safety profile using CTCAE v3 criteria
Dose-limiting toxicity of PR-104
Pharmacokinetics of PR-104 and its alcohol metabolite in blood
Anti-tumor activity
Biomarkers of tumor hypoxia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, PR104 and F-18-fluoromisonidazole in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Proacta, Incorporated at 3 sites in 2 countries.
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 11 inclusion and 22 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: finished, as of the sponsor's last update on 1 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, New Zealand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Maximum tolerated dose of PR-104 (time frame: 3 weeks (cycle 1)). It is what the study was designed to measure, not a finding.
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 1 Jun 2011.