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.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: filgrastim  Drug: interferon gamma	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      Hoag Memorial Hospital Presbyterian, Newport Beach,  California,  92658,  United States
Indiana
      Bloomington Hospital, Bloomington,  Indiana,  47402,  United States
      St. Vincent Hospital and Health Care Center, Indianapolis,  Indiana,  46260,  United States
Nebraska
      Bergan Mercy Medical Center, Omaha,  Nebraska,  68124,  United States

Study chairs or principal investigators

Robert O. Dillman,  Study Chair,  Cancer Biotherapy Research Group   

Study ID Numbers:  CDR0000077951; CBRG-9212; NCI-V92-0155; NBSG-9212
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002505
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08