Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer

Tracking Information
First Submitted Date ICMJE	December 7, 2001
First Posted Date ICMJE	January 27, 2003
Last Update Posted Date	January 6, 2014
Study Start Date ICMJE	December 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00027833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
Official Title ICMJE	Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEA/B7.1 Vaccine Administered With Chemotherapy, Alone or in Combination With Tetanus Toxoid, as Compared to Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma
Brief Summary	RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy. PURPOSE: Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer.
Detailed Description	OBJECTIVES: Determine the safety of ALVAC-CEA-B7.1 vaccine and chemotherapy, with or without tetanus toxoid, vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma.; Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.; Arm I: Patients receive a priming dose of tetanus toxoid. Beginning 2 weeks later, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine subcutaneously (SC) once weekly for 3 weeks. Two weeks after the third vaccine administration, patients receive tetanus toxoid and ALVAC-CEA-B7.1 vaccine SC on day 1 and irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.; Arm II: Patients receive ALVAC-CEA-B7.1 vaccine and chemotherapy as in arm I.; Arm III: Patients receive chemotherapy as in arm I. After completion of chemotherapy, patients with partial or complete response may receive ALVAC-CEA-B7.1 vaccine SC once weekly on weeks 1-3 and 6. PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Colorectal Cancer
Intervention ICMJE	Biological: ALVAC-CEA-B7.1 vaccine; Biological: tetanus toxoid; Drug: FOLFIRI regimen; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium
Study Arms	Not Provided
Publications *	Kaufman HL, Lenz HJ, Marshall J, Singh D, Garett C, Cripps C, Moore M, von Mehren M, Dalfen R, Heim WJ, Conry RM, Urba WJ, Benson AB 3rd, Yu M, Caterini J, Kim-Schulze S, Debenedette M, Salha D, Vogel T, Elias I, Berinstein NL. Combination chemotherapy and ALVAC-CEA/B7.1 vaccine in patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Aug 1;14(15):4843-9. doi: 10.1158/1078-0432.CCR-08-0276.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma; No clinically active CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 6 months Hematopoietic: Lymphocyte count at least 1,000/mm^3; Granulocyte count at least 1,500/mm^3; Platelet count at least 100,000/mm^3; Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); AST/ALT less than 3 times ULN (5 times ULN if liver metastases present); Alkaline phosphatase less than 3 times ULN (5 times ULN if liver metastases present); No hepatocellular dysfunction; No cirrhosis Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No uncontrolled coronary artery disease; No symptomatic congestive heart failure Pulmonary: No uncontrolled chronic obstructive lung disease Gastrointestinal: No unsolved bowel obstruction or subobstruction; No uncontrolled Crohn's disease; No ulcerative colitis; No concurrent chronic diarrhea Immunologic: HIV negative; No immunocompromised patients; No diagnosis of altered immune function, including: Lupus erythematosus Sjogren's syndrome Scleroderma Myasthenia gravis Goodpasture's disease Addison's disease Hashimoto's thyroiditis Active Graves' disease; No known allergy to egg products or neomycin; No prior adverse reaction to tetanus toxoid-containing vaccines Other: No significant comorbid medical function; No uncontrolled infection; No unstable diabetes mellitus; No uncontrolled thyroid function abnormalities; No other malignancy within the past 5 years except basal cell carcinoma or adequately treated carcinoma in situ of the cervix; No other medical illness or mental status that would preclude study participation; No prior severe toxicity to adjuvant chemotherapy; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No prior CEA-directed immunotherapy; No other concurrent immunotherapy Chemotherapy: At least 6 months since prior adjuvant chemotherapy; No prior chemotherapy for metastatic disease; No other concurrent chemotherapy Endocrine therapy: No concurrent daily use of systemic steroids; No concurrent nonsubstitutional hormonal therapy Radiotherapy: No prior radiotherapy to more than 50% of all nodal groups; No concurrent radiotherapy except for palliative purposes involving less than 20% of bone marrow reserve Surgery: No prior major organ allograft; Recovered from prior surgery Other: At least 28 days since prior investigational products; No other concurrent investigational products
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00027833
Other Study ID Numbers ICMJE	CDR0000069082; CPMC-14534; CPMC-BB-IND-9911; FCCC-01015; APL-COL13; NCI-G01-2033
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Herbert Irving Comprehensive Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: Howard L. Kaufman, MD Herbert Irving Comprehensive Cancer Center
PRS Account	National Cancer Institute (NCI)
Verification Date	September 2003
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP