Tumor Cell Vaccine in Treating Patients With Advanced Cancer

Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific

Intervention: filgrastim (Drug); recombinant interferon gamma (Drug); colony-stimulating factor therapy (Procedure); interferon therapy (Procedure); tumor cell-derivative vaccine therapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Cancer Biotherapy Research Group

Official(s) and/or principal investigator(s):
Robert O. Dillman, MD, FACP, Study Chair, Affiliation: Cancer Biotherapy Research Group

RATIONALE: Vaccines made from the patient's cancer cells may make the body build an immune response and kill their tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer.

Official title: RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE

Study design: Treatment

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hoag Memorial Hospital Presbyterian, Newport Beach, California 92658, United States

Bloomington Hospital, Bloomington, Indiana 47402, United States

St. Vincent Hospital and Health Care Center, Indianapolis, Indiana 46260, United States

Bergan Mercy Medical Center, Omaha, Nebraska 68124, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 1992
Last updated: December 15, 2007