A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer
Trial Information
A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Clinical response (patients with evaluable disease)
Safety Issue:
No
Principal Investigator
Charles L. Wiseman, MD, FACP
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
SVMC-ONC-222
NCT ID:
NCT00002475
Start Date:
April 1991
Completion Date:
June 2009
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Kidney Cancer
- Lung Cancer
- Malignant Mesothelioma
- Pancreatic Cancer
- stage III colon cancer
- stage IV colon cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- recurrent colon cancer
- stage III renal cell cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IIIC breast cancer
- stage IV non-small cell lung cancer
- pulmonary carcinoid tumor
- recurrent malignant mesothelioma
- stage IV pancreatic cancer
- Breast Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Colorectal Neoplasms
- Lung Neoplasms
- Mesothelioma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| St. Vincent Medical Center - Los Angeles | Los Angeles, California 90057 |
