or
forgot password

Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Male Breast Cancer, Recurrent Breast Cancer, Skin Metastases, Stage IV Breast Cancer

Thank you

Trial Information

Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases


PRIMARY OBJECTIVES:

I. To evaluate the safety of chemoimmunotherapy with topical imiquimod and Abraxane in
breast cancer patients with recurrent chest wall disease or cutaneous metastasis.

II. To evaluate the anti-tumor effects of chemoimmunotherapy with topical imiquimod and
Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous
metastasis.

SECONDARY OBJECTIVES:

I. To examine whether treatment with chemoimmunotherapy consisting of topical imiquimod and
Abraxane augments endogenous tumor specific immunity.

II. To assess the effect of chemoimmunotherapy on circulating transforming growth factor
(TGF)-beta levels.

OUTLINE:

Patients receive Abraxane intravenously (IV) over 30 minutes on days 1, 8, and 15 and apply
topical imiquimod to cutaneous lesions once daily (QD) on days 1-4, 8-11, 15-18, and 22-25.
Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.


Inclusion Criteria:



- Patients with advanced stage refractory breast cancer

- Progressive or relapsed disease following standard therapy with chemotherapy and/or
surgery, and/or radiation

- Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous
metastatic lesions

- Patients must be at least 7 days from last chemotherapy and 30 days from local
radiotherapy and/or systemic steroids

- Patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are
eligible

- White blood cell count >= 1000/ul

- Absolute neutrophil count (ANC) >= 1200/ul

- Platelets > 75,000/ul

- Serum creatinine =< 2.0 mg/dL, a creatinine clearance > 60 ml/min

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 X upper limit
normal (ULN)

- Total bilirubin < 2 X ULN

- Patients must have a Performance Status Score (Eastern Cooperative Oncology Group
[ECOG] Scale) =< 2

- Patients must have recovered from major infections and/or surgical procedures and, in
the opinion of the investigator, not have a significant active concurrent medical
illness precluding protocol treatment

- Men and women of reproductive ability must agree to contraceptive use during the
study and for 1 month after imiquimod/Abraxane treatment is discontinued

Exclusion Criteria:

- Patients with prior allergic reaction to taxanes

- Patients with any clinically significant active autoimmune disease requiring active
treatment with systemic steroids or other immunomodulators

- Pregnant or breast-feeding women

- Patients with peripheral neuropathy >= Grade 2

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Anti-tumor effects of imiquimod as assessed by modified World Health Organization (WHO) criteria

Outcome Description:

Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

Outcome Time Frame:

Baseline and then every 4 weeks until week 24

Safety Issue:

No

Principal Investigator

Lupe Salazar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6578

NCT ID:

NCT00821964

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Skin Metastases
  • Stage IV Breast Cancer
  • Breast Cancer
  • Stage IV
  • cream
  • topical
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Skin Neoplasms
  • Breast Neoplasms, Male

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109