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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006126
Recruitment Status : Withdrawn (Unable to accrue subjects.)
First Posted : March 8, 2004
Last Update Posted : November 13, 2015
National Cancer Institute (NCI)
Information provided by:
Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Kidney Cancer Lung Cancer Melanoma (Skin) Testicular Germ Cell Tumor Drug: busulfan Drug: cyclophosphamide Drug: etoposide Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study
Study Start Date : September 1999
Primary Completion Date : April 2001
Study Completion Date : April 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006126

Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Richard K. Burt, MD Robert H. Lurie Cancer Center
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Responsible Party: Richard Burt, MD, Northwestern University Identifier: NCT00006126    
Other Study ID Numbers: NU 99H2
First Posted: March 8, 2004    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by Northwestern University:
stage IV renal cell cancer
recurrent renal cell cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IV breast cancer
recurrent breast cancer
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Breast Neoplasms
Lung Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urogenital Neoplasms
Urologic Diseases
Neoplasms, Glandular and Epithelial
Fludarabine phosphate