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Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer


Phase 2
N/A
65 Years
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer


OBJECTIVES:

- Determine the feasibility of tandem high-dose chemotherapy comprising melphalan,
carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®)
followed by autologous peripheral blood stem cell transplantation and helical
tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB, IIIC,
or IV breast cancer.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients undergo stem cell collection.

- Course 1: Patients receive high-dose melphalan IV with or without trastuzumab
(Herceptin®). One day later, patients undergo autologous peripheral blood stem cell
(PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.

- Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV
continuously over 4 days followed by autologous PBSC transplantation.

After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with
stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients
with stage IV disease undergo radiotherapy using helical tomotherapy or standard
radiotherapy to oligometastatic sites.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

- Stage IIIB or IIIC disease, meeting both of the following criteria:

- Must have received prior neoadjuvant or adjuvant therapy

- Must have undergone lumpectomy or mastectomy

- Stage IV disease, meeting all of the following criteria:

- Only 1-3 organ sites with disease involvement after induction chemotherapy

- Achieved at least a partial response after induction chemotherapy

- No more than 3 lesions in the organ sites combined

- Inflammatory breast cancer allowed

- Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6
months

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 65 and under

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- Karnofsky 80-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- SGOT or SGPT ≤ 2 times upper limit of normal

- Bilirubin ≤ 1.5 mg/dL

Renal

- Creatinine ≤ 1.2 mg/dL

- Creatinine clearance ≥ 70 mL/min

Cardiovascular

- LVEF ≥ 55% by MUGA or echocardiogram

Pulmonary

- FEV_1 ≥ 60% of predicted

- DLCO ≥ 60% of the lower limit of predicted value

- Oxygen saturation > 92% on room air

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No autoimmune disorders

- No immunosuppressive condition

- No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy except trastuzumab (Herceptin®)

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior radiotherapy to adjacent or involved sites of disease that would preclude
study radiotherapy

Surgery

- See Disease Characteristics

Other

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to relapse and/or progression

Outcome Time Frame:

5 years post treatment

Safety Issue:

No

Principal Investigator

George Somlo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

05042

NCT ID:

NCT00182793

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • inflammatory breast cancer
  • male breast cancer
  • recurrent breast cancer
  • invasive ductal breast carcinoma with predominant intraductal component
  • invasive ductal breast carcinoma
  • medullary ductal breast carcinoma with lymphocytic infiltrate
  • mucinous ductal breast carcinoma
  • Paget disease of the breast with invasive ductal carcinoma
  • papillary ductal breast carcinoma
  • tubular ductal breast carcinoma
  • invasive lobular breast carcinoma with predominant in situ component
  • invasive lobular breast carcinoma
  • comedo ductal breast carcinoma
  • Breast Neoplasms

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010