- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00027833
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
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
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Ontario
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Ottawa, Ontario, Kanada, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Kanada, H2W 1S6
- McGill University
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35243
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Los Angeles, California, Vereinigte Staaten, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20007
- Lombardi Cancer Center
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Florida
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Tampa, Florida, Vereinigte Staaten, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Vereinigte Staaten, 60611
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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New York
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New York, New York, Vereinigte Staaten, 10032
- Herbert Irving Comprehensive Cancer Center
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97213-2967
- Earle A. Chiles Research Institute at Providence Portland Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
- Fox Chase Cancer Center
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Scranton, Pennsylvania, Vereinigte Staaten, 18510
- Scranton Hematology-Oncology
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Maskierung: Keine (Offenes Etikett)
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Howard L. Kaufman, MD, Herbert Irving Comprehensive Cancer Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Infektionen
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Bakterielle Infektionen
- Bakterielle Infektionen und Mykosen
- Grampositive bakterielle Infektionen
- Darmtumoren
- Rektale Erkrankungen
- Clostridium-Infektionen
- Kolorektale Neubildungen
- Tetanus
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Topoisomerase-Inhibitoren
- Mikronährstoffe
- Vitamine
- Calciumregulierende Hormone und Wirkstoffe
- Topoisomerase I-Inhibitoren
- Gegenmittel
- Vitamin B-Komplex
- Fluorouracil
- Leucovorin
- Irinotecan
- Kalzium
- Levoleucovorin
Andere Studien-ID-Nummern
- CDR0000069082
- CPMC-14534
- CPMC-BB-IND-9911
- FCCC-01015
- APL-COL13
- NCI-G01-2033
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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