Status:
COMPLETED
In Vivo Angiostatin Generation Using Tissue Plasminogen Activator and Captopril in Treating Patients With Progressive Metastatic Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 t...
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 ge...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00086723
Start Date
July 1 2003
End Date
January 1 2006
Last Update
June 11 2012
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013