Patient case: 73-year-old female with breast cancer; genetic feature: CDKN2A

Clinical trial: Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Summary: 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: 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.

Eligibility: 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

Relevance to patient case: not relevant