Vaccine Therapy With or Without Cyclophosphamide and Doxorubicin in Women With Stage IV Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with cyclophosphamide and doxorubicin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide and doxorubicin when given with vaccine therapy in treating women with stage IV breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage IV disease

• Stable disease for ≥ 28 days

• Measurable or evaluable disease OR no evidence of disease

• Not eligible for potentially curative therapy

• Adequately treated CNS metastases are allowed

• Hormone receptor status:

• Not specified

• HER-2/neu status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

Hepatic

• Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)

• AST and ALT ≤ 2 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

Renal

• Creatinine < 2.0 mg/dL

Cardiovascular

• Ejection fraction ≥ 45% by echocardiogram or MUGA

Pulmonary

• Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required

Immunologic

• No active autoimmune disease requiring systemic immunosuppressive therapy, including any of the following:

• Inflammatory bowel disease

• Systemic vasculitis

• Scleroderma

• Psoriasis

• Multiple sclerosis

• Hemolytic anemia

• Immune-mediated thrombocytopenia

• Rheumatoid arthritis

• Systemic lupus erythematosus

• Sjögren's syndrome

• Sarcoidosis

• Other rheumatologic disease

• HIV negative

• No active acute or chronic infection

• No allergy to corn

Other

• No other malignancy within the past 5 years except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer

• No active major medical or psychosocial problem that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 28 days since prior biologic therapy

• No other concurrent biologic therapy, including trastuzumab (Herceptin®)

Chemotherapy

• Prior adjuvant chemotherapy allowed

• Prior doxorubicin and cyclophosphamide allowed

• Prior doxorubicin dose combined with planned study therapy dose must not exceed a lifetime cumulative dose of ≥ 450 mg/m^2

• More than 28 days since prior systemic chemotherapy

• No other concurrent systemic chemotherapy

Endocrine therapy

• More than 28 days since prior systemic corticosteroids

• Concurrent hormonal or endocrine therapy allowed

• No concurrent systemic corticosteroids

Radiotherapy

• More than 28 days since prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 28 days since prior participation in another investigational drug trial

• No other concurrent investigational drugs

• Concurrent bisphosphonates allowed