A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
allogeneic tumor cell vaccine
+ autologous tumor cell vaccine
+ recombinant interferon alfa
Urogenital Diseases+45
+ Adenocarcinoma
+ Adenoma
Treatment Study
Summary
Study start date: April 1, 1991
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the safety and clinical effects of autologous or allogeneic active-specific intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon gamma-treated tumor cells followed by sargramostim (GM-CSF) in patients with advanced cancer. OUTLINE: This is a pilot study. Patients are stratified by tumor type. Tumor tissue is removed from the patient and incubated with interferon alfa or interferon gamma for 72-96 hours. (If autologous tumor cells are not available, an allogeneic vaccine is prepared.) Harvested activated cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV. 48-72 hours after cyclophosphamide administration, patients receive tumor cell vaccine intradermally. Patients also receive sargramostim (GM-CSF) subcutaneously prior to vaccine administration and once daily for the next 8 days. Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity. Patients with responding or stable disease after completion of course 3 may receive additional courses. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 18-24 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cancer not amenable to cure or long-term control by surgery, radiotherapy, chemotherapy, or hormonal manipulations, including the following tumor types: Colon cancer Lung cancer Renal cancer Breast cancer Pancreatic cancer Metastatic disease or subclinical disease at high risk of recurrence No brain metastases unresponsive to irradiation or surgery Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent pulmonary disease Other: No prior or concurrent autoimmune disease No other prior or concurrent major medical illness HIV negative No clinical evidence of AIDS Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
St. Vincent Medical Center - Los Angeles
Los Angeles, United StatesOpen St. Vincent Medical Center - Los Angeles in Google Maps