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
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: aldesleukin (Drug); carboplatin (Drug); cyclophosphamide (Drug); cyclosporine (Drug); recombinant interferon gamma (Drug); thiotepa (Drug); autologous bone marrow transplantation (Procedure); peripheral blood stem cell transplantation (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Herbert Irving Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Charles S. Hesdorffer, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center
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.
Clinical Details
Official title: High-Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support And One Of Two Regimens Aimed At Modifying Immune Reconstitution In Women With High Risk Stage 2 And Stage 3 Breast Cancer
Study design: Treatment, Randomized, Active Control
Detailed description:
OBJECTIVES:
- Determine the response, disease-free survival (DFS), and overall survival of women with
high-risk stage II or III breast cancer treated with high-dose cyclophosphamide,
thiotepa, and carboplatin with autologous marrow and/or peripheral blood stem cell
transplantation.
- Determine the safety of immunomodulation consisting of cyclosporine and interferon gamma
versus low-dose interleukin-2 in this patient population.
- Determine parameters associated with immune activation and autologous graft-versus-host
disease.
- Determine which immunomodulation regimen is more efficacious with respect to DSF.
OUTLINE: This is a randomized study. Patients are stratified according to stage (II vs III),
age, lymph node status, and inflammatory histology. Patients are randomized to one of two
immunomodulation arms.
Autologous harvest of at least 1 million CD34+ cells /kg or 400 million mononuclear cells/kg
must be achieved.
All patients receive cyclophosphamide IV continuously and thiotepa IV continuously over 96
hours on days - 6 through -3 and carboplatin IV over 5 hours daily on days -6 through -3.
Patients undergo autologous bone marrow and/or peripheral blood stem cell transfusion on day
0.
- Arm I: Patients receive cyclosporine IV over 4 hours twice a day, beginning on day 0 and
continuing until discharge from the hospital, and interferon gamma subcutaneously (SC)
every 2 days on days 7-28.
- Arm II: Patients receive interleukin-2 SC daily for 28 days following recovery of blood
counts.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then annually for 5 years.
PROJECTED ACCRUAL: A total of 70 patients (30 with stage II disease and 40 with stage III
disease) will be accrued over 2 years.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Herbert Irving Comprehensive Cancer Center, New York, New York 10032, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 1996
Last updated: May 23, 2008
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