Clinical trial · Interventional
Vaccine Therapy With or Without Cyclophosphamide and Doxorubicin in Women With Stage IV Breast Cancer
A Phase I Vaccine Safety and Chemotherapy Dose-Finding Trial of an Allogeneic GM-CSF-Secreting Breast Cancer Vaccine Given in a Specifically Timed Sequence With Immunomodulatory Doses of Cyclophosphamide and Doxorubicin
NCT00093834CI-TRIAL-00067704completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with cyclophosphamide and doxorubicin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide and doxorubicin when given with vaccine therapy in treating women with stage IV breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic GM-CSF-secreting breast cancer vaccine | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Toxicity of vaccine w/ & w/o cyclophosphamide+doxorubicin by history and phys. exam. at 28-42 days after each vaccination, 56-84 days after third vaccination, 6 months after first vaccination, and annually after first vaccination
- timeFrame
- 4 years
- measure
- Toxicity of vaccine w/ & w/o cyclophosphamide+doxorubicin by CBC w/ differential at days 7, 14, 21, and 28-42 days after each vaccination, 56-84 days after third vaccination, 6 months after first vaccination, and annually after first vaccination
- timeFrame
- 4 years
- measure
- Toxicity of vaccine w/ & w/o cyclophosphamide+doxorubicin by comprehensive metabolic panel at day 7 and 28-42 days after each vaccination, 56-84 days after third vaccination, 6 months after first vaccination, and annually after first vaccination
- timeFrame
- 4 years
- measure
- Immune resp. of HER-2/neu by serum antibody titers, delayed hypersensitivity to HER-2/neu-derived peptides, and CD4+ T-cell resp. by ELISPOT at days 28-42 after each vaccination and days 56-84 after third vaccination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Stage IV disease * Stable disease for ≥ 28 days * Measurable or evaluable disease OR no evidence of disease * Not eligible for potentially curative therapy * Adequately treated CNS metastases are allowed * Hormone receptor status: * Not specified * HER-2/neu status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome) * AST and ALT ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 5 times ULN Renal * Creatinine \< 2.0 mg/dL Cardiovascular * Ejection fraction ≥ 45% by echocardiogram or MUGA Pulmonary * Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required Immunologic * No active autoimmune disease requiring systemic immunosuppressive therapy, including any of the following: * Inflammatory bowel disease * Systemic vasculitis * Scleroderma * Psoriasis * Multiple sclerosis * Hemolytic anemia * Immune-mediated thrombocytopenia * Rheumatoid arthritis * Systemic lupus erythematosus * Sjögren's syndrome * Sarcoidosis * Other rheumatologic disease * HIV negative * No active acute or chronic infection * No allergy to corn Other * No other malignancy within the past 5 years except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer * No active major medical or psychosocial problem that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 28 days since prior biologic therapy * No other concurrent biologic therapy, including trastuzumab (Herceptin®) Chemotherapy * Prior adjuvant chemotherapy allowed * Prior doxorubicin and cyclophosphamide allowed * Prior doxorubicin dose combined with planned study therapy dose must not exceed a lifetime cumulative dose of ≥ 450 mg/m\^2 * More than 28 days since prior systemic chemotherapy * No other concurrent systemic chemotherapy Endocrine therapy * More than 28 days since prior systemic corticosteroids * Concurrent hormonal or endocrine therapy allowed * No concurrent systemic corticosteroids Radiotherapy * More than 28 days since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 28 days since prior participation in another investigational drug trial * No other concurrent investigational drugs * Concurrent bisphosphonates allowed
References
Publications (1)
- RESULTEmens LA, Armstrong D, Biedrzycki B, Davidson N, Davis-Sproul J, Fetting J, Jaffee E, Onners B, Piantadosi S, Reilly RT, Stearns V, Tartakovsky I, Visvanathan K, Wolff A. A phase I vaccine safety and chemotherapy dose-finding trial of an allogeneic GM-CSF-secreting breast cancer vaccine given in a specifically timed sequence with immunomodulatory doses of cyclophosphamide and doxorubicin. Hum Gene Ther. 2004 Mar;15(3):313-37. doi: 10.1089/104303404322886165. No abstract available. PMID 15018740