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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


Phase 3
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Charles S. Hesdorffer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068387

NCT ID:

NCT00008203

Start Date:

May 1996

Completion Date:

May 2008

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032