Know Cancer

forgot password

A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Trial of TNF-Bound Colloidal Gold (CYT-6091) by Intravenous Administration in Subjects With Advanced Solid Organ Malignancies



- 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.


- 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


- 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


- 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


- Recovered from prior therapy

- More than 3 weeks since prior biological or cytotoxic agents (6 weeks for

- No known requirment for palliative treatment

- No concurrent surgery

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091)

Safety Issue:


Principal Investigator

Steven K. Libutti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

April 2009

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda, Maryland  20892-1182
NCI - Surgery Branch Bethesda, Maryland  20892-1201