Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

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.

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