NCT00086723

Brief 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 work in treating patients with progressive metastatic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

2.5 years

First QC Date

July 8, 2004

Last Update Submit

June 7, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Angiostatin production

Interventions

recombinant tissue plasminogen activatorBIOLOGICAL
captoprilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Interventions

Tissue Plasminogen ActivatorCaptopril

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsProlineImino AcidsAmino Acids, CyclicAmino Acids

Study Officials

  • William J. Gradishar, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

July 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

US(1)