Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapy may interfere with the growth of the cancer cells. It is not yet known which post-transplant biological therapy regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have stage II or stage III breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herbert Irving Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Carboplatin; Cyclophosphamide; Cyclosporine; Cyclosporins; Interferon-gamma; Interferons; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Stage II with at least 10 lymph nodes involved with malignancy OR

• Stage III (any T3b-T4, N2 or N3, M0)

• Ineligible for other high priority national or institutional study

• No metastasis to brain (confirmed by CT or MRI)

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 to physiologic 65

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2 times normal

Renal:

• Creatinine less than 1.5 times normal

Cardiovascular:

• LVEF at least 45%

Other:

• HIV negative

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 cycles of prior chemotherapy required

• Stage II patients must have completed 4-6 courses of doxorubicin and/or taxol-based adjuvant chemotherapy

• Stage III patients must have achieved complete or partial response to 4-6 courses of doxorubicin and/or taxol-based induction chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified