• Disease-free survival [ Designated as safety issue: No ]
  

• Overall survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine whether the use of autologous peripheral blood stem cell transplantation followed by immunotherapy with activated T cells, low-dose interleukin-2, and sargramostim (GM-CSF) in women with stage IIIB or IV breast cancer or other solid tumors improves progression-free survival (PFS) compared to a reported mean PFS in patients treated with second-line chemotherapy with matching inclusion criteria by published trials.
• Determine if this regimen improves clinical response and overall survival.
• Perform sequential immune monitoring studies, including phenotyping, cytotoxic assays, EliSpots for IFNγ, selected T-cell repertoire (Vβ analysis), HER2/new tetramer analysis, and serum tumor markers.
• Test correlations between immune function tests and clinical endpoints.

OUTLINE: Patients are stratified according to disease (stage IIIB breast vs stage IV breast vs solid tumors). Patients with breast cancer are also stratified according to tumor classification (chemosensitive vs chemoresistant).

Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 5 days followed by peripheral blood mononuclear cell (PBMC) collection for PBSCT and generation of activated T cells (ATC). The PBMC are treated ex vivo with monoclonal antibody OKT3 to form ATC. The ATC are expanded for 12-14 days in interleukin-2 (IL-2).

Patients then receive high-dose chemotherapy. Patients with chemosensitive disease receive cyclophosphamide IV, thiotepa IV, and carboplatin IV on days -6, -5, and -4. Patients with chemoresistant disease receive ifosfamide IV, carboplatin IV, and etoposide IV on days -8 to -3. Patients undergo autologous PBSC transplantation on day 0.

Patients then receive ATC IV over 15-20 minutes three times per week starting day +4 for three weeks and then once weekly for at least 6 doses. Patients also receive low-dose IL-2 SC daily and sargramostim (GM-CSF) SC twice weekly on days 4 until last infusion of ATC.

Patients are followed at 3 and 6 months post-transplantation and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (10-15 with solid tumors) will be accrued.

DISEASE CHARACTERISTICS:

• Women with histologically confirmed stage IIIB or IV carcinoma of the breast

  • Bilateral disease allowed
  • Concurrent intraductal or lobular carcinoma in situ allowed

  • Measurable or evaluable recurrent metastatic disease

    • Nonmeasurable disease allowed if tumor or metastatic disease has been previously removed or successfully treated OR

• Patients with diagnosis of solid tumor including but not limited to:

  • Ovarian carcinoma
  • Ewing sarcoma
  • Small cell lung cancer
  • Germ cell tumor
• Relapsed solid tumor after prior PBSC transplantation allowed

• No clinical evidence of active brain metastases

  • Patients with treated brain metastases (i.e., those who have received definitive radiation, chemotherapy, and/or underwent surgery) and are stable are eligible
• No significant CNS disease

• Hormone receptor status:

  • Estrogen or progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

• Female (breast cancer)
• Male or Female (solid tumor)
• Menopausal status not specified
• Karnofsky performance status 70-100%
• ECOG performance status 0-2
• Life expectancy at least 3 months
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 50,000/mm^3
• Hemoglobin greater than 8 g/dL
• Bilirubin less than 1.5 times normal
• AST, ALT, and alkaline phosphatase < 5 times upper normal
• Creatinine less than 1.8 mg/dL
• Creatinine clearance at least 60 mL/min
• BUN less than 1.5 times normal
• No myocardial infarction (MI) within the past year
• No history of MI (> 1 year ago) with current coronary symptoms requiring medication
• No current history of angina/coronary symptoms requiring medication
• No clinical evidence of congestive heart failure requiring medical management
• No significant congestive heart failure
• No other uncontrolled or significant cardiovascular disease
• Ejection fraction at least 45% at rest by MUGA
• PFT-FEV_1 at least 60% predicted
• DLCO2 at least 60% predicted
• FVC at least 60% predicted
• No other malignancy within the past 3 years
• No other serious medical or psychiatric illness that would preclude study participation
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior bone marrow transplantation allowed
• More than 4 weeks to leukapheresis since prior hormonal therapy
• No radiation to the axial skeleton within 4 weeks of leukapheresis
• No concurrent hormonal therapy for breast cancer
• No more than 1 prior chemotherapy regimen except as part of treatment on protocol WSU-2006-130
• No prior solid organ allograft
• At least 7 days since prior corticosteroids except therapeutic doses for respiratory ailments or adrenal insufficiency
• Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed
• Concurrent hormones for non-disease related conditions (e.g., insulin for diabetes) allowed