Breast Cancer Clinical Trial
Official title:
Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study
Verified date | November 2015 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of peripheral stem cell transplantation in
treating patients who have melanoma or small cell lung, breast, testicular, or kidney cancer
that is metastatic or that cannot be treated with surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2001 |
Est. primary completion date | April 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 59 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable solid tumor
of one of the following types: Small cell lung cancer Extensive stage (disease outside the
hemithorax) or relapsed Prior cytoreduction with platinum/etoposide regimen and/or taxane
containing regimen Epithelial breast cancer Stage IV or relapsed disease Prior
cytoreduction with adriamycin and/or taxane regimens Testicular germ cell cancer Failure
to achieve complete remission with platinum based chemotherapy Relapsed disease with at
least one salvage regimen Melanoma Metastatic disease that has failed at least one
biologic response modifier such as interleukin-2 or interferon Relapsed disease involving
a visceral organ Renal cell cancer Metastatic disease that has failed at least one
biologic response modifier such as interleukin-2 or interferon Relapsed disease involving
a visceral organ HLA matched or one antigen mismatched related donor available Hormone
receptor status: Not specified PATIENT CHARACTERISTICS: Age: Under physiologic 60 Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL unless due to Gilbert's disease SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure LVEF at least 40% Pulmonary: DLCO at least 45% of predicted OR FEV1/FVC at least 50% of predicted Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy that would preclude study Surgery: See Disease Characteristics |
Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Northwestern University | National Cancer Institute (NCI) |
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