Overview

Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery

Status:
Withdrawn
Trial end date:
2001-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northwestern University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Busulfan
Cyclophosphamide
Etoposide
Fludarabine
Fludarabine phosphate
Criteria
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