GoldBamboo.com - Knowledge is strong medicine
  

Repeated Bone Marrow Transplantation in Treating Patients With Advanced Breast Cancer - Article


  Not Signed In - Sign In / Register






Ifosfamide

Ifex



Clinical Trial: Repeated Bone Marrow Transplantation in Treating Patients With Advanced Breast Cancer

This study is no longer recruiting patients.

Sponsored by: Louisiana State University
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of repeated use of high-dose chemotherapy plus bone marrow transplantation and samarium 153 in treating patients who have stage IV breast cancer.

Condition Treatment or Intervention Phase
stage IV breast cancer
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: radiation therapy
 Procedure: isotope therapy
 Procedure: colony-stimulating factor therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: cytokine therapy
 Drug: bone marrow ablation with stem cell support
 Drug: carboplatin
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: doxorubicin
 Drug: filgrastim
 Drug: fluorouracil
 Drug: ifosfamide
 Drug: melphalan
 Drug: paclitaxel
 Drug: samarium Sm 153 lexidronam pentasodium
 Drug: thiotepa
Phase I
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Samarium 153 and Autologous Bone Marrow Transplantation for Stage IV Breast Cancer

Further Study Details: 

Study start: March 1997

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of samarium 153 used sequentially with autologous bone marrow transplantation for metastatic breast cancer. II. Determine the response rate, median duration of response, and overall survival of patients who respond to induction therapy followed by 2 cycles of high dose chemotherapy and stem cell support.

PROTOCOL OUTLINE: This is a dose escalation study. Patients are first treated with salvage chemotherapy for no more than 4 cycles. At least a partial remission must be achieved. Peripheral blood stem cells (PBSC) are collected following the administration of filgrastim (granulocyte colony-stimulating factor; G-CSF). After recovery from the prior chemotherapy, high dose chemotherapy begins. Paclitaxel is administered as a 24 hour infusion on day -7. Melphalan IV is administered over 1 hour on days -6 and -5. PBSC are infused on day 0. A second regimen of high dose chemotherapy begins after at least 42 days posttransplant and as long as at least partial remission occurs after previous chemotherapy. Samarium 153 is administered on day -14. Cohorts of 3 patients each are treated at each dose level until the maximum tolerated dose is reached (defined as dose at which the dose limiting toxicity occurs in 3 or more of 6 patients). Cyclophosphamide, thiotepa, and carboplatin are infused over 24 hours on days -7 through -4. PBSC are infused on day 0 followed by G-CSF IV. The phase II dose of samarium 153 is one dose level below the MTD determined in the Phase I portion of this study. Patients are followed until death.

PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  21 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 21-65
  • Sex: Female
  • Performance status: 0-1
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin less than 1.5 mg/dL; SGOT and SGPT normal
  • Renal: Creatinine less than 1.5 mg/dL
  • Cardiovascular: Ejection fraction of at least 50%; No symptomatic coronary artery disease
  • Pulmonary: FEV1 and DLCO greater than 50% of predicted
  • Other: Not pregnant; Not HIV positive; Not hepatitis B surface antigen positive; No uncontrolled infection; No other prior malignancy within 5 years except: Curatively treated in situ adenocarcinoma of the cervix; Curatively treated nonmelanoma skin cancer

Location Information


Louisiana
      Louisiana State University School of Medicine, Shreveport,  Louisiana,  71130-3932,  United States

Study chairs or principal investigators

Benjamin Barry Weinberger,  Study Chair,  Louisiana State University   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065786; LSU-97447; NCI-V97-1341
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003086
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Ifosfamide.

November 18, 2008



Page Updated: June 1, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.