Unspecified Adult Solid Tumor, Protocol SpecificPhase 1/2NCT00086723
In Vivo Angiostatin Generation Using Tissue Plasminogen Activator and Captopril in Treating Patients With Progressive Metastatic Cancer
A Phase 1/2 study testing recombinant tissue plasminogen activator and captopril in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin. Angiostatin may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they… 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?
- recombinant tissue plasminogen activator and captopril
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jan 2006
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of progressive metastatic cancer, excluding hematologic malignancies (i.e., leukemia or lymphoma)
- Measurable disease not required
- Must have received at least 1 prior systemic treatment for metastatic disease
- No known CNS involvement
- CNS involvement allowed provided it is successfully controlled by prior surgery or radiotherapy and there is no current requirement for corticosteroids
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal
- Albumin normal
- PT and aPTT normal
- Fibrinogen > lower limit of normal
Renal
- Creatinine no greater than 1.8 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No history of stroke, transient ischemic attack, or symptoms of cerebral ischemia
- No history of angioedema with captopril
- No severe or uncontrolled hypertension (i.e., systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg)
- No congestive heart failure requiring therapy
- No chronic hypotension (e.g., systolic blood pressure less than 100 mm Hg)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- Potassium no greater than 5.2 mmol/L
- No active internal bleeding
- No history of seizures
- No psychiatric disorder that would preclude the giving of informed consent or study follow-up
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No uncontrolled or active bacterial, viral, or invasive fungal infection
- No recent trauma
- No medical indication for anticoagulation
- No contraindication to captopril
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy
- No concurrent immunomodulator therapy
Chemotherapy
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 4 weeks since prior endocrine therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
- No recent intracranial or intraspinal surgery
- No concurrent surgery
Other
- More than 48 hours since prior anticoagulation agents (e.g., warfarin or heparin)
- More than 3 weeks since prior investigational agents
- No concurrent anticoagulation agents, aspirin, or nonsteroidal anti-inflammatory drugs
- No other concurrent investigational agent
- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
- Concurrent bisphosphonates allowed for metastatic bone disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: Phase I/II Trial of In Vivo Angiostatin Generation With Tissue Plasminogen Activator (tPA) and Captopril in Patients With Progressive, Metastatic Cancer
RATIONALE: Tissue plasminogen activator and captopril may help the body generate angiostatin. Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they work in treating patients with progressive metastatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity of captopril and tissue plasminogen activator (tPA) in patients with progressive metastatic cancer.
- Determine the in vivo generation of angiostatin by western analysis in patients treated with this regimen.
Secondary
- Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive tissue plasminogen activator (tPA) IV over 6 hours and oral captopril twice daily on days 1-5. Courses repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Cohorts of 3-6 patients receive escalating doses of tPA and captopril until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Not specified.
- Being tested
- recombinant tissue plasminogen activator, captopril
- 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.
recombinant tissue plasminogen activatorBiological
captoprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiostatin production
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startJul 2003
- Primary completionJan 2006
- Study completionJan 2006
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.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William J. Gradishar, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086723
- Sponsor's protocol ID
- NCI 00B9
- Other IDs
- NU-NCI-00B9
- Status last verified
- Jun 2012
- First submitted
- 8 Jul 2004
- Last updated
- 11 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of In Vivo Angiostatin Generation With Tissue Plasminogen Activator (tPA) and Captopril in Patients With Progressive, Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00086723
- Acronym / sponsor ID
- NCI 00B9
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 12 Jul 2004 (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: Tissue plasminogen activator and captopril may help the body generate angiostatin. Angiostatin may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of tissue plasminogen activator and captopril and to see how well they work in treating patients with progressive metastatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity of captopril and tissue plasminogen activator (tPA) in patients with progressive metastatic cancer.
- Determine the in vivo generation of angiostatin by western analysis in patients treated with this regimen.
Secondary
- Determine the antitumor effect of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive tissue plasminogen activator (tPA) IV over 6 hours and oral captopril twice daily on days 1-5. Courses repeat every 14 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Cohorts of 3-6 patients receive escalating doses of tPA and captopril until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Not specified.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| recombinant tissue plasminogen activator | Biological | – |
| captopril | Drug | – |
Primary outcome
Angiostatin production
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 11 Jun 2012.
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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.
William J. Gradishar, MD principal investigator
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant tissue plasminogen activator and captopril in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Northwestern University at 1 site 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?
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 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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 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?
Angiostatin production. 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 11 Jun 2012.