RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE
OBJECTIVES: I. Determine the toxic effects and side effects associated with administration
of autologous tumor cell vaccine together with adjuvant interferon gamma or sargramostim
(GM-CSF) in patients with advanced cancer. II. Determine the rate of conversion of delayed
tumor hypersensitivity in patients receiving subcutaneous injections of irradiated
autologous tumor cells (autologous vaccine). III. Determine the effect of autologous
vaccines on in vitro assays of immune antitumor activity. IV. Determine the failure free
survival associated with the use of autologous tumor cell line vaccines in patients with
advanced cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, tumor type, disease stage, remission status (complete vs partial),
prior therapy, progressive disease (yes vs no), and performance status (ECOG 0-1 vs 2).
Patients are randomized into one of two treatment arms. Arm I: Patients receive vaccination
with irradiated autologous tumor cells subcutaneously (SQ) on week 1 and then autologous
tumor cell vaccine plus interferon gamma SQ on weeks 2 and 3, and then monthly beginning on
week 8 and continuing until week 24. Arm II: Patients receive vaccination with irradiated
autologous tumor cells as in arm I and then autologous tumor cell vaccine plus sargramostim
(GM-CSF) SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week
24.
PROJECTED ACCRUAL: A total of 20-30 patients from each major tumor type (breast, lung,
prostate, colorectal, sarcoma, renal, melanoma) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cancer with documented regional lymph
node or distant metastases not considered cured by standard therapy Achievement of maximum
benefit (i.e., CR or PR) from cytoreductive therapy prior to entry allowed Eligible tumor
types include: Breast Prostate Colorectal Sarcoma Lung Renal cell Melanoma Large resected
primary cancers at risk for recurrence and for which no standard adjuvant therapy
available Viable autologous tumor cells derived from an autologous tumor cell line
required No active brain metastases Previously treated and responsive brain metastases
allowed unless corticosteroid dependent
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 3,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% Hepatic:
Bilirubin less than 2.0 mg/dL PT and PTT normal Renal: Creatinine less than 2.0 mg/dL
Cardiovascular: No myocardial infarction within the past 6 months No congestive heart
failure requiring medication Pulmonary: Respiratory reserve must be reasonable No
requirement for supplemental oxygen No dyspnea at rest
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed No concurrent
biologic therapy (including cyclosporine) Chemotherapy: At least 24 hours since prior
cyclophosphamide At least 4 weeks since other systemic antineoplastic chemotherapy and
recovered Endocrine therapy: Homeopathic corticosteroids allowed At least 4 weeks since
prior corticosteroids No other concurrent corticosteroids Radiotherapy: Prior radiotherapy
allowed Surgery: Prior surgery allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert O. Dillman, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Biotherapy Research Group
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000077951
NCT ID:
NCT00002505
Start Date:
August 1992
Completion Date:
May 2006
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
| Bloomington Hospital | Bloomington, Indiana 47402 |
| Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| St. Vincent Hospital and Health Care Center | Indianapolis, Indiana 46260 |
