Protocol Number: 03-C-0300

Title:

A Phase II Randomized Trial Comparing TNFerade[TM] Biologic with Capecitabine and Radiation Therapy Followed by Surgical Resection Versus Capecitabine and Radiation Therapy Followed by Surgical Resection for the Treatment of Rectal Cancer

Number:

03-C-0300

Summary:

This study will evaluate the effectiveness of the experimental drug, TNFerade[TM], in combination with radiation therapy and capecitabine, a chemotherapy drug, before surgery to remove cancer. Up to 95 patients will participate over a 3-year period in this study. They will be assigned at random to two groups: those to receive TNFerade[TM], capecitabine, and radiation therapy; and those to receive capecitabine and radiation therapy. TNFerade[TM] is a modified live virus called an adenovirus, normally causing an illness similar to a cold.

Patients ages 18 or older with Stage II or III cancer and who do not have a history of serious heart disease may be eligible for this study. Patients will undergo a physical examination and blood collection. Before patients are assigned randomly to groups, 10 will be treated with 4 x(10)10 pu, a dose level of TNFerade[TM], followed by chemotherapy with capecitabine and radiation, to evaluate the drug and determine whether the tumor can be removed by surgery. Then two patient groups will be assigned to receive the drug before administration of chemotherapy and radiation: one with a dose of 4 x(10)10 pu, and the other with 4 x(9)10 pu. TNFerade[TM] will be injected into four sections of the tumor. There will be four biopsies done of the tumor, one before the treatment is given, and then at three other stages. All patients will receive additional chemotherapy after the tumor is removed through surgery, and all will receive radiation therapy to the tumor 5 days a week, over a period of 5 to 7 weeks. All patients will receive capecitabine orally twice a day during the weeks of radiation therapy. During chemotherapy treatment, about 2 tablespoons of blood will be drawn for examination. If patients develop side effects, the dose of capecitabine may be reduced or delayed. Blood levels will be measured for TNFerade[TM] as well.

Following completion of 5 weeks of chemotherapy and radiation, patients will have a 4-week rest. If a physical exam and lab results show that it is safe to proceed with surgery, patients will be scheduled for surgery at the Clinical Center. Then about 3 weeks after surgery, patients will return to NIH for a blood test and a computed tomography (CT) scan to see if the tumor has returned and to watch for side effects from treatment. If there is no sign of the tumor, patients will begin standard chemotherapy with appropriate drugs. If not all of the tumor has been removed, there may be additional radiation therapy or surgery. Patients will be asked to return to NIH every 3 months for up to 3 years, for a CT scan and lab tests.

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): 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):

Pathologic Complete Response

Disease Free Survival

Overall Survival

Gene Expression

Proteomic Profiles

Recruitment Keyword(s):

Rectal Cancer

Condition(s):

Rectal Neoplasms

Investigational Drug(s):

TNFerade TM

Investigational Device(s):

None

Interventions:

Drug: TNFerade TM

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):

Jemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. Erratum in: CA Cancer J Clin 2002 Mar-Apr;52(2):119. CA Cancer J Clin 2002 May-Jun;52(3):181-2.

Chari RS, et al, Preoperative radiation and chemotherapy in the treatment of adenocarcinoma of the rectum. Ann Surg. 1995 Jun;221(6):778-86; discussion 786-7.

Grann A, et al, Preliminary results of preoperative 5-fluorouracil, low-dose leucovorin, and concurrent radiation therapy for clinically resectable T3 rectal cancer. Dis Colon Rectum. 1997 May;40(5):515-22.

• 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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