Status:
COMPLETED
TNF-Bound Colloidal Gold in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 sid...
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. S...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00356980
Start Date
May 1 2006
End Date
April 1 2009
Last Update
March 15 2012
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201