Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Monoclonal Antibody Therapy Plus Sargramostim in Treating Patients With Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI UKMC-95GI24CB NCI-H97-1184

Objectives

I. Determine the effect on the immune system of 3H1 anti-idiotype monoclonal 
antibody mixed with sargramostim (GM-CSF) versus 3H1 anti-idiotype monoclonal 
antibody alum precipitate mixed with GM-CSF in patients with stage II or III 
colorectal cancer.

II. Monitor toxic effects in these patients.

III. Follow patients for recurrent disease.

Entry Criteria

Disease Characteristics:

Histologically proven Stage II and III colorectal cancer
 -CEA positive Dukes B and C 

Prior/Concurrent Therapy:

Biologic therapy:
 No prior or concurrent allergy to murine protein

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No concurrent use of nonsteroidal anti-inflammatory agents or cimetidine or
  H2 receptor antagonists
 No concurrent participation in experimental protocols

Patient Characteristics:

Age:
 18 and over

Performance Status:
 SWOG 0-1

Hematopoietic:
 Hemoglobin at least 10 g/dL

Hepatic:
 BUN no greater than 1.5 times normal
 Bilirubin no greater than 1.5 times normal

Renal:
 Creatinine no greater than 1.5 times normal

Other:
 No serious medical illness
 No psychosis
 Not pregnant or nursing
  Negative pregnancy test
  Fertile patients must use effective contraception
 No other prior malignancies except basal cell or squamous cell skin cancer or
  carcinoma in situ of the cervix

Expected Enrollment

A total of 30 patients will be accrued for this study.

Outline

This is a randomized study.

Patients receive either intracutaneous injections of 3H1 anti-idiotype 
antibody with alum or intramuscular injection of 3H1 anti-idiotype antibody 
with QS-21 adjuvant. Patients receive biweekly treatment for four 
immunizations and then every four weeks for a total of two years. (These 
regimens are closed)

Patients are randomized to receive one of two treatment arms.

Arm I:  Patients receive 3H1 anti-idiotype antibody with sargramostim (GM-CSF).

Arm II:  Patients receive GM-CSF on days 1-7 and 3H1 anti-idiotype antibody 
with alum on day 5.

Patients receive weekly subcutaneous injections for 4 weeks, then then once 
every 4 weeks for 2 years, then every 8 weeks for 3 years in the absence of 
disease progression. 

Trial Contact Information

Trial Lead Organizations

Lucille P. Markey Cancer Center at University of Kentucky

Timothy Meeker, MD, Protocol chair(Contact information may not be current)		Ph: 606-323-8043