Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence.

Detailed Description
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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.

Official Title
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A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide

Conditions
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Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer

Intervention / Treatment
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* Biological: allogeneic tumor cell vaccine
* Biological: autologous tumor cell vaccine
* Biological: recombinant interferon alfa
* Biological: recombinant interferon gamma
* Biological: sargramostim
* Drug: cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: allogeneic tumor cell vaccine|nan|
|Biological: autologous tumor cell vaccine|nan|
|Biological: recombinant interferon alfa|nan|
|Biological: recombinant interferon gamma|nan|
|Biological: sargramostim|nan|
|Drug: cyclophosphamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response (patients with evaluable disease) |  |  | 
| Duration of response (patients with evaluable disease) |  |  | 
| Survival (patients with evaluable disease) |  |  | 
| Time to recurrence (patients without evaluable disease) |  |  | 
| Survival (patients without evaluable disease) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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