Clinical trial · Interventional
Biological Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer
A PILOT TRIAL OF INTERLEUKIN-2 WITH G-CSF AS PRIMING THERAPY FOR PERIPHERAL BLOOD STEM CELL HARVESTING IN PATIENTS WITH ADVANCED BREAST CANCER: STAMP V HIGH DOSE CHEMOTHERAPY, STEM CELL INFUSION AND POST-INFUSION G-CSF AND INTERLEUKIN-2
- 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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Peripheral stem cell transplantation combined with biological therapy may be an effective treatment for breast cancer. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 with filgrastim to stimulate cell production in treating patients with stage IIIB, stage IV, metastatic, or recurrent breast cancer who will undergo peripheral stem cell transplantation.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed advanced breast cancer not eligible for (or patient refuses participation in) a higher priority phase III SWOG study Local stage IIIB/IV disease, i.e.: Inflammatory Fixed to chest wall Fixed to axillary lymph nodes Recurrent disease Metastatic disease Disease stable or responsive to standard dose systemic chemotherapy Measurable or evaluable disease required except: Unevaluable stage IV disease (beyond draining lymph nodes) eligible following surgical resection, radiotherapy, or chemotherapy Less than 30% bone marrow involvement on aspiration and biopsy No active brain metastases CT or MRI required unless asymptomatic and no history of brain metastases No large symptomatic pleural effusion PATIENT CHARACTERISTICS: Age: Under 65 Performance status: SWOG 0 or 1 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% on MUGA No angina No history of myocardial infarction Exercise stress test without definite ischemia required for: History suggestive of coronary disease Diabetes mellitus Hypertension Age over 50 Pulmonary: FEV1 greater than 60% of predicted or greater than 2.0 liters DLCO greater than 60% of predicted Other: No prior hemorrhagic cystitis No active systemic infection No active CNS disease (e.g., seizures) HIV negative No second malignancy within 2 years except: Localized nonmelanomatous skin cancer Carcinoma in situ of the cervix Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy and recovered No more than 2 different prior chemotherapy regimens for metastatic disease No prior mitomycin or nitrosourea Lifetime cumulative doxorubicin dose less than 350 mg per square meter Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since radiotherapy and recovered Surgery: At least 3 weeks since major surgery and recovered
References
Publications (0)
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