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Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT00022230
Recruitment Status : Withdrawn (PI left Institution)
First Posted : January 27, 2003
Last Update Posted : May 5, 2015
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy together with biological therapy and to see how well they work in treating patients with stage II or stage III breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: aldesleukin Biological: filgrastim Biological: sargramostim Biological: therapeutic autologous lymphocytes Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Phase 1 Phase 2

Detailed Description:


  • Determine the toxic effects of sequential paclitaxel (or other taxane), doxorubicin, and cyclophosphamide followed by immunotherapy with activated T cells, interleukin-2, and sargramostim (GM-CSF) in patients with high-risk stage II or III breast cancer.
  • Determine the disease-free survival and overall survival of patients treated with this regimen.
  • Determine the immune function of patients treated with this regimen.

OUTLINE: Patients are stratified according to number of positive lymph nodes (less than 4 nodes vs 4-9 nodes vs 10 or more nodes), type of taxane chemotherapy during study (paclitaxel vs other taxane), and prior treatment with 2 of 3 study chemotherapy agents (yes vs no).

Patients receive doxorubicin IV on day 1 and filgrastim (G-CSF) on days 3-10 of 3 consecutive 14-day courses. Patients then receive paclitaxel or another taxane IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses. Patients then receive cyclophosphamide IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses. Patients who enroll after previously receiving 2 of these 3 chemotherapy drugs may receive the third. Treatment continues in the absence of disease progression or unacceptable toxicity.

After recovery from chemotherapy, patients undergo peripheral blood mononuclear cell (PBMC) collection. The PBMC are treated ex vivo with monoclonal antibody OKT3 to form activated T cells (ATC). The ATC are expanded for up to 14 days in interleukin-2 (IL-2).

At 3-4 weeks after PBMC collection, patients receive ATC IV over 15-30 minutes weekly for 8 weeks. Patients also receive IL-2 subcutaneously (SC) daily and sargramostim (GM-CSF) SC twice weekly beginning 3 days before the first ATC infusion and continuing until 7 days after completion of ATC therapy.

Patients are followed every 3 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 40-60 patients will be accrued for this study within 4-5 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Chemotherapy With Taxol, Adriamycin, and Cytoxan (TAC), Multiple Infusions of Activated T Cells (ATC), Interleukin-2 (IL-2) and GM-CSF for High Risk Breast Cancer With and Without Her2/Neu Overexpression. (Phase I/II)
Study Start Date : January 2000
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Toxicity
  2. Disease-free survival
  3. Overall survival
  4. Immune functions

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage II or III adenocarcinoma of the breast
  • High-risk disease

    • At least 4 positive lymph nodes
    • Fewer than 4 positive lymph nodes considered high-risk if one of the following is present:

      • HER2/neu-positive disease
      • Enlarged axillary nodes
      • Extra capsular extension of tumor from lymph node
      • Dermal lymphatic invasion
      • Vascular invasion
      • Bilateral disease
      • Familial breast cancer
      • T4 locally advanced disease
  • Clinically chemosensitive to prior paclitaxel (or other taxane), doxorubicin, and cyclophosphamide

    • No relapse after chemotherapy
  • No clinical evidence of brain metastases
  • Hormone receptor status:

    • Estrogen and progesterone receptor status known



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100% OR
  • ECOG 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
  • SGOT less than 1.5 times normal


  • Creatinine less than 1.8 mg/dL
  • Creatinine clearance at least 60 mL/min
  • BUN less than 1.5 times normal


  • Ejection fraction at least 45% by MUGA
  • No uncontrolled or significant cardiovascular disease
  • No myocardial infarction within the past year
  • No significant congestive heart failure


  • FEV_1 at least 60% predicted
  • DLCO at least 60% predicted
  • FVC at least 60% predicted


  • No other malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer
  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Prior standard chemotherapy with anthracyclines or combination chemotherapy involving a combination of taxanes, doxorubicin, and/or cyclophosphamide allowed

Endocrine therapy:

  • No concurrent hormonal therapy for breast cancer
  • Concurrent hormonal therapy for nondisease-related conditions (e.g., insulin for diabetes) allowed
  • Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed


  • Not specified


  • Prior complete resection of tumor allowed


  • Prior successful neoadjuvant therapy allowed
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022230

United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908-4735
Sponsors and Collaborators
Roger Williams Medical Center
Study Chair: Lawrence G. Lum, MD, DSc Roger Williams Medical Center
More Information

Responsible Party: Lawrence Lum, Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT00022230     History of Changes
Other Study ID Numbers: CDR0000068797
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Roger Williams Medical Center:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents