Protocol Number: 07-C-0043

Title:

An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects with Primary and Metastatic Cancer Undergoing Surgical Resection

Number:

07-C-0043

Summary:

This study will evaluate how an experimental drug for cancer treatment gets into tumors and normal tissue. This drug, a new method of delivering tumor necrosis factor (TNF), is called TNF-bound colloidal gold, or CYT-6091. TNF is normally produced by cells in the immune system and has also been found to have anti-cancer effects. Doses that might be high enough to shrink tumors cause serious side effects, so researchers have focused on getting TNF directly to the tumor. This study uses microscopic gold particles that have TNF bound or attached to their surface. Attaching the gold molecule to TNF may decrease severity of side effects when TNF is given to humans.

Patients aged 18 and older who do not have bleeding disorders or serious problems of the heart or lungs may be eligible for this study. They will undergo a complete physical and medical history as well as a complete blood count and blood chemistry, urine analysis, pregnancy test, chest X-ray, and electrocardiogram as part of the process to determine.

Patients who are eligible and who have surgery scheduled will be admitted to the hospital. They will get one injection of CYT-6091 at 12, 24, 48, or 72 hours before surgery. A long flexible thin plastic tube (catheter) is used to administer CYT-6091. It is threaded into a large vein in the arm that leads to the heart. After that line is inserted, patients will be given some fluids through it, for 2 to 3 hours before the dose of CYT-6091. Then CYT-6091 will be given for about a minute. Researchers will monitor patients' hearts and breathing. They will also check blood pressure, heart, breathing, and temperature every 15 minutes for 7 or 8 times, and then routinely to watch for any side effects. During surgery, pieces of tumors and pieces of normal tissue near the tumor or incision will be removed for this research study. Taking the extra pieces of normal tissue will not increase the operation time or cause an additional risk. The rest of the tumor will be sent to the laboratory for analysis. After surgery, patients will receive routine care, including pain medications, and get specific information about what to expect after surgery. Six weeks after they are discharged, patients will return to the clinic for a routine visit and then about every 3 to 6 months for 3 years. At each visit, they will have a physical examination and have blood drawn. They may have computed tomography or magnetic resonance imaging scans, if appropriate.

This study is unlikely to have a direct benefit for participants. However, knowledge gained will provide valuable information about how CYT-6091 travels to tumors and normal tissue.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

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 Necrosing Factor

Tumor Angiogenesis

Nanoparticles

Phase 0 Trial

Recruitment Keyword(s):

Metastatic Cancer

Condition(s):

Metastatic Cancer

Investigational Drug(s):

CYT-6091 (Colloidal Gold TNF)

Investigational Device(s):

None

Interventions:

Drug: CYT-6091 (Colloidal Gold TNF)

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

Creaven PJ, Plager JE, Dupere S, Huben RP, Takita H, Mittelman A, Proefrock A. Phase I clinical trial of recombinant human tumor necrosis factor. Cancer Chemother Pharmacol. 1987;20(2):137-44.

• 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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