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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

  1. Angiostatin production

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startJul 2003
  3. Primary completionJan 2006
  4. Study completionJan 2006

Resources

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
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

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.

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