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.

Condition	Treatment or Intervention	Phase
recurrent testicular cancer extensive stage small cell lung cancer Stage IV Melanoma Stage IV Renal Cell Cancer stage II testicular cancer Recurrent Small Cell Lung Cancer stage III testicular cancer stage IV breast cancer recurrent breast cancer recurrent renal cell cancer Recurrent Melanoma	Drug: busulfan  Drug: cyclophosphamide  Drug: etoposide  Drug: fludarabine	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the toxicity of allogeneic peripheral blood stem cell transplantation in patients with metastatic or unresectable small cell lung cancer, breast cancer, testicular germ cell cancer, melanoma, or renal cell cancer. II. Determine the efficacy of this regimen in these patients.

PROTOCOL OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously for 4 or 5 days prior to peripheral blood stem cell harvest. Patients are assigned to one of three conditioning regimens, depending on disease. Group A (small cell lung cancer): Patients receive cyclophosphamide IV over 1-2 hours on days -7 and -6, etoposide IV over 4 hours on day -5, and total body irradiation twice daily on days -4 to -1. Group B (breast cancer and testicular germ cell cancer): Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 14 doses. Patients then receive cyclophosphamide IV over 1-2 hours on days -3 and -2. Group C (renal cell cancer and melanoma): Patients receive fludarabine IV daily on days -8 to -4 and cyclophosphamide IV on days -3 and -2. All groups: Patients receive allogeneic peripheral blood stem cells IV over 10-20 minutes on day 0. Patients are followed weekly for 3 months, at 6 and 12 months, and then yearly for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.

Ages Eligible for Study:  up to  59 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

Study chairs or principal investigators

Richard K. Burt,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000068146; NU-99H2; NCI-G00-1838
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006126
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08