NCT00006126

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

Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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.

Conditions

• Breast Cancer
• Kidney Cancer
• Lung Cancer
• Melanoma (Skin)
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	fludarabine phosphate
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	radiation therapy

Timeline

• Start date: 1999-09-01
• Primary completion: 2001-04-01
• Completion: 2001-04-01
• First posted: 2004-03-08
• Last updated: 2015-11-13