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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001193 |
Purpose
This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breast and regional lymph nodes; convertible partial responders and clinical complete responders with residual disease on biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest wall and regional lymph nodes excluding the axilla. Both groups of responders will be randomized to receive either systemic consolidation therapy with high dose melphalan (180 mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory group will not receive further therapy since, historically, they have done well following induction and local therapy, with maintenance therapy alone.
Patients with metastatic breast cancer will be assessed for response throughout induction therapy. Complete and convertable partial responders will receive consolidative therapy and be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms Neoplasm Metastasis |
Procedure: high dose melphalan and autologous bone marrow transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 1984 |
| Estimated Study Completion Date: | September 2000 |
This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breast and regional lymph nodes; convertible partial responders and clinical complete responders with residual disease on biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest wall and regional lymph nodes excluding the axilla. Both groups of responders will be randomized to receive either systemic consolidation therapy with high dose melphalan (180 mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory group will not receive further therapy since, historically, they have done well following induction and local therapy, with maintenance therapy alone.
Patients with metastatic breast cancer will be assessed for response throughout induction therapy. Complete and convertable partial responders will receive consolidative therapy and be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients must have a histologically documented diagnosis of mammary carcinoma and evaluable disease in the breast.
Diagnostic tissue must be reviewed at NIH.
All ICB patients must meet Haagensen's clinical criteria of ICB.
Patients with metastatic breast cancer must have evaluable disease.
There must be no history of prior cytotoxic therapy.
There must be no history of previous malignancy except for cured nonmelanoma skin cancer and cervical carcinoma in situ.
Performance status (Karnofsky scale) must be greater than 30 for patients with metastatic breast cancer.
Staging workup must be negative for distant metastases in Stage III patients.
WBC count greater than 4000 per mm(3) and platelet count greater than 100,000 per mm(3).
Normal hepatic and renal function, unless due to tumor involvement.
Patients must be willing to give informed consent and be geographically accessible for follow up.
No history of other malignant neoplasms except for curatively treated nonmelanoma skin cancer or surgically cured carcinoma of the cervix in situ.
Patients must not be poor medical or psychiatric risks because of non-malignant systemic disease which would preclude them being subjected to any of the treatments in this protocol.
Contacts and Locations More Information
| Study ID Numbers: | 840216, 84-C-0216 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001193 |
| Health Authority: | United States: Federal Government |
|
Autologous Melphalan Stage III Transplantation |
|
Melphalan Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |
