Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
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|ClinicalTrials.gov Identifier: NCT00095862|
Recruitment Status : Terminated
First Posted : November 9, 2004
Last Update Posted : February 5, 2018
RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: allogeneic GM-CSF-secreting breast cancer vaccine Biological: recombinant interferon alfa Drug: cyclophosphamide||Phase 1 Phase 2|
- Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors.
- Determine the clinical response, time to progression, and survival of patients treated with this regimen.
- Correlate clinical response with immunological response in patients treated with this regimen.
OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed at 2 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor|
|Study Start Date :||November 2004|
- Safety, tolerability, and feasibility
- Clinical response
- Time to progression
- Correlation of clinical response with immunological response
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): NCT00095862
|United States, California|
|Glendale Memorial Hospital Comprehensive Cancer Center|
|Glendale, California, United States, 91204|
|Hollywood Presbyterian Medical Center|
|Los Angeles, California, United States, 90027-0902|
|Los Angeles, California, United States, 90057|
|Study Chair:||Charles L. Wiseman, MD, FACP|