Protocol Number: 06-C-0167

Title:

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

Number:

06-C-0167

Summary:

Background:

-Tumor necrosis factor (TNF) has anti-cancer effects, but in doses high enough to shrink tumors it causes serious side effects.

-In studies in laboratory mice, TNF that was attached, or "bound," to microscopic gold particles collected in tumors and destroyed tumor cells with fewer side effects, because the higher TNF levels were only in the tumor and less of the drug was released into the blood.

-Gold-bound TNF (CYT6091) is an experimental drug that has not been given to humans before.

Objectives:

-To determine the highest dose of CYT6091 that can safely be given to patients with solid tumors and to identify the drug's side effects.

-To determine how the drug behaves in the body (how it is used and eliminated) and its effects on tumor tissue.

Eligibility:

-Patients 18 years of age or older with a solid tumor that has spread beyond the primary organ site.

-Patients whose cancer cannot be treated successfully with standard therapies or for which conventional treatment is not available.

Design:

-Patients are admitted to the hospital for approximately 4 days for CYT6091 infusions. The drug is given through a catheter (plastic tube) that is threaded from a large arm vein to the heart. Doses are given 2 weeks apart; two doses are considered one treatment course. Patients whose tumor remains stable or shrinks after the first treatment course may be offered additional courses until their disease progresses or side effects become unacceptable.

-Patients are evaluated throughout the study with tests to determine the size and extent of tumor and the impact of treatment. This includes periodic blood tests, physical examinations, scans and x-rays. Additional blood tests are done for research. After treatment ends, patients are followed with the same evaluations at longer intervals.

-Patients with tumors that are easy to biopsy may be asked to undergo a biopsy to evaluate the amount of CYT6091 in the tumor. A piece of normal tissue next to the tumor is also biopsied. Additional biopsies may be requested in patients who receive additional courses of therapy.

-Up to 60 patients may be enrolled in the study.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Tumor Necrosis Factor

Metastatic Cancer

Cytokine

Maximum Tolerated Dose

Dose Limiting Toxicity

Recruitment Keyword(s):

Solid Tumor

Solid Organ Cancer

Metastatic Solid Organ Cancer

Condition(s):

Advanced Solid Organ Malignancy

Solid Organ Cancer

Investigational Drug(s):

CYT-6091

Investigational Device(s):

None

Interventions:

Drug: CYT-6091

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Kimura K, Taguchi T, Urushizaki I, Ohno R, Abe O, Furue H, Hattori T, Ichihashi H, Inoguchi K, Majima H, et al. Phase I study of recombinant human tumor necrosis factor. Cancer Chemother Pharmacol. 1987;20(3):223-9.

Taguchi T. Phase I study of recombinant human tumor necrosis factor (rHu-TNF:PT-050). Cancer Detect Prev. 1988;12(1-6):561-72.

Tracey KJ, Beutler B, Lowry SF, Merryweather J, Wolpe S, Milsark IW, Hariri RJ, Fahey TJ 3rd, Zentella A, Albert JD, et al. Shock and tissue injury induced by recombinant human cachectin. Science. 1986 Oct 24;234(4775):470-4.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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