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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002854 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 combination chemotherapy plus peripheral stem cell transplantation in treating patients who have advanced cancer.
Condition | Intervention | Phase |
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Cancer |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: ifosfamide Drug: mesna Drug: paclitaxel Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE I PILOT STUDY OF SEQUENTIAL HIGH DOSE CYCLES OF CISPLATIN, CYCLOPHOSPHAMIDE, ETOPOSIDE AND IFOSFAMIDE, CARBOPLATIN AND TAXOL WITH AUTOLOGOUS STEM CELL SUPPORT |
Estimated Enrollment: | 6 |
Study Start Date: | December 1994 |
OBJECTIVES:
OUTLINE: At least 4 weeks prior to chemotherapy, patients undergo stem cell collection following filgrastim (G-CSF) mobilization. Sufficient stem cells to support 2 courses of chemotherapy are required. Autologous bone marrow is collected as an adjuvant if stem cell harvest is inadequate.
Patients then receive high dose cisplatin, etoposide, and cyclophosphamide over 10 days, followed the next day by infusion of one fourth of the allotted stem cells, with the remaining allotment infused 2 days later. G-CSF is given for granulocyte support.
Beginning no sooner than 14 weeks from the start of the first course of chemotherapy, stable and responding patients receive high dose paclitaxel, carboplatin, and ifosfamide over 5 days, followed 2 days later with one-fourth of the allotted stem cells, with the remaining allotment infused the following day. G-CSF is given for granulocyte support. Groups of 3-6 patients are treated with escalating doses of paclitaxel until the maximum tolerated dose for this regimen is determined.
Patients are followed monthly for 1 year, every 3 months for 1 year, then as needed at the physician's discretion for at least 5 years.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose of paclitaxel studied.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced carcinomas of the following types:
Breast carcinoma that is ineligible for or patient has refused participation in a higher priority protocol in the following categories:
Stage IV disease following partial response (PR) or complete response (CR) to surgery, chemotherapy, or radiotherapy
Stage III/IV ovarian cancer
Primary soft tissue sarcoma with high-grade disease greater than 10 cm or that is metastatic
Malignant melanoma in the following categories:
Osteosarcoma that is ineligible for or refused participation in higher priority protocols
The following diseases rendered surgically NED or that achieved PR/CR on any chemotherapeutic, radiotherapeutic, or immunotherapeutic regimen also eligible:
No current histologically confirmed bone marrow metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No contraindication to the following procedures:
No second malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 |
Study Chair: | George Somlo, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000065102, CHNMC-IRB-94098, NCI-V96-1042 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002854 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage II breast cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IV gastric cancer recurrent gastric cancer localized osteosarcoma metastatic osteosarcoma stage IIIB breast cancer recurrent pancreatic cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer stage IV anal cancer |
recurrent anal cancer stage IV esophageal cancer recurrent esophageal cancer stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent Wilms tumor and other childhood kidney tumors advanced adult primary liver cancer recurrent adult primary liver cancer recurrent osteosarcoma recurrent gallbladder cancer recurrent extrahepatic bile duct cancer recurrent small intestine cancer |
Neuroectodermal Tumors, Primitive Rectal Neoplasms Pancreatic Neoplasms Anal Cancer Wilms' Tumor Neuroepithelioma Osteogenic Sarcoma Etoposide Breast Neoplasms Esophageal Cancer Carboplatin Ewing's Sarcoma Neuroectodermal Tumors Malignant Mesenchymal Tumor Esophageal Disorder |
Paclitaxel Sarcoma Esophageal Diseases Gallbladder Neoplasms Stomach Cancer Antineoplastic Agents, Phytogenic Anus Neoplasms Mesna Immunologic Factors Esophageal Neoplasms Cyclophosphamide Bile Duct Cancer, Extrahepatic Etoposide phosphate Melanoma Liver Neoplasms |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions Ifosfamide Cisplatin |
Radiation-Sensitizing Agents Paclitaxel Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Isophosphamide mustard |