Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

Launched by ONYVAX · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the safety and tolerability of monoclonal antibody 105AD7 anti-idiotypic vaccine and ONYCR1, ONYCR2, and ONYCR3 allogeneic adenocarcinoma cell-based vaccines in patients with locally advanced or metastatic adenocarcinoma of the colon or rectum.
* Determine any immunological response to these treatment regimens in these patients.
* Determine the 6-month and 1-year survival of these patients after receiving these treatment regimens.
* Determine the tumor response to these treatment regimens in these patients.

OUTLINE: This is an open-label study. Patients are assigne...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the colon or rectum
• • Not amenable to curative surgery and either refractory to or inappropriate for chemotherapy
• • Patient must have received adequate or appropriate prior chemotherapy for metastatic disease
• PATIENT CHARACTERISTICS:
• Age:
• • 18 and over
• Performance status:
• • Karnofsky 60-100%
• Life expectancy:
• • At least 3 months
• Hematopoietic:
• • Not specified
• Hepatic:
• • Not specified
• Renal:
• • Not specified
• Other:
• • No other prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ
• • No history of immunodeficiency
• • No concurrent unstable medical condition that would preclude study
• • No psychological, familial, sociological, or geographical condition that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • At least 1 month since prior immunomodulatory drugs
• Chemotherapy:
• • See Disease Characteristics
• • At least 4 weeks since prior chemotherapy
• • No concurrent chemotherapy
• Endocrine therapy:
• • At least 1 month since prior corticosteroids
• • No concurrent corticosteroids
• Radiotherapy:
• • At least 6 weeks since prior radiotherapy
• Surgery:
• • See Disease Characteristics
• Other:
• • At least 4 weeks since other prior anticancer drug
• • No other concurrent investigational anticancer agent