- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00356980
TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal gold in treating patients with advanced solid tumors.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors.
- Determine the toxicities of CYT-6091 in these patients.
Secondary
- Determine the pharmacokinetics of CYT-6091 in these patients.
- Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091.
- Determine if antitumor effects of CYT-6091 occur in these patients.
OUTLINE: This is an open-label, sequential cohort, dose-escalation study.
Patients receive TNF-bound colloidal gold (CYT-6091) IV on days 1 and 15 (course 1). Approximately 4-6 weeks later, patients are re-staged and responding patients may receive another course of therapy. Patients may receive up to 3 re-treatment courses.
Cohorts of 3-6 patients receive escalating doses of CYT-6091 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity.
Blood samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic and pharmacodynamic analyses.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for the next year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
-
Bethesda, Maryland, United States, 20892-1201
- NCI - Surgery Branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Advanced and/or metastatic disease
- Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists
- Measurable or evaluable metastatic disease
- No lymphoma or other hematologic malignancy
No known brain metastases
- Previously treated brain metastases with no evidence of recurrence allowed
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.5 mg/dL
- ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present)
- Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
- Prothrombin time ≤ 1.5 times ULN
- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
- LVEF ≥ 45% by echocardiogram or thallium stress test for patients > 50 years of age or history of cardiovascular disease
- FEV_1 and DLCO > 30% of predicted for patients with a history of pulmonary disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis)
- Localized chronic infections, such as mild acne or tinea pedis allowed
- No acute or chronic viral hepatitis
- No known bleeding disorder
No other concurrent life-threatening illness, including any of the following:
- Unstable angina
- Severe oxygen-dependent chronic obstructive pulmonary disease
- End-stage liver disease
- No known active renal disease or renal insufficiency as evidenced by serum creatinine > 2.0 mg/dL
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas)
- No known requirment for palliative treatment
- No concurrent surgery
- No other concurrent anticancer therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of response
|
Duration of stable disease
|
Overall response
|
Pharmacokinetic profile of CYT-6091
|
Measurements of CYT-6091 in tumor biopsies
|
Tumor biopsy histology and gene expression after treatment
|
Immunogenicity of CYT-6091
|
Electron microscopy of biopsy to determine presence of colloidal gold
|
Response of target and nontarget lesions
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 060167
- 06-C-0167
- NCI-P6062
- CYT-6091-06-01
- CDR0000486917
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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