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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 18 and over Other CTCT 06-11 NCT00493883

Trial Description

Summary

The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.

The study has the following objectives:

• Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver.

• Evaluate patient experience and toxicities associated with TheraSphere treatment

• Evaluate predisposing factors that may influence results and toxicity

Further Study Information

This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.

1. Range of patients who can be offered TheraSphere®

2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity

3. Survival time

4. Determine response in relation to histology and other parameters

5. Ability to tolerate repeat treatments

6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Eligibility Criteria

Inclusion Criteria:

1. Age >= 18.

2. Cancer visible in liver on CT,MR,US or PET scan.

3. Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma.

4. Life expectancy greater than 2 months

5. Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.)

6. Patients have tried and/or are aware of all FDA approved therapies for their condition.

Exclusion Criteria:

1. Vascular shunt that cannot be corrected.

2. Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body.

3. Pregnancy

4. Hematologic primary such as lymphoma, leukemia, myeloma.

5. Body weight 300 lbs. and above

6. Evidence of portal hypertension, splenomegaly or ascites.

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer Treatment Centers of America at Southwestern Regional Medical Center

Douglas A. Kelly, M.D.

Principal Investigator

Michele M Sumner, BS, CCRC

Ph: 1-877-896-3698

JJ Stark, BS, CCRC

Ph: 1-877-896-3698

U.S.A.
Oklahoma
	Tulsa
	Cancer Treatment Centers of America at Southwestern Regional Medical Center
		Michele M Sumner, BS, CCRC	Ph: 877-896-3698
		JJ Stark, BS, CCRC	Ph: 1-877-896-3698
		Douglas A. Kelly, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00493883
Information obtained from ClinicalTrials.gov on July 16, 2008