A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)
Safety Issue:
Yes
Principal Investigator
Steven K. Libutti, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Food and Drug Administration
Study ID:
060167
NCT ID:
NCT00356980
Start Date:
May 2006
Completion Date:
April 2009
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
| NCI - Surgery Branch | Bethesda, Maryland 20892-1201 |
