GoldBamboo.com - Knowledge is strong medicine
  

Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma - Article


  Not Signed In - Sign In / Register






Filgrastim

G-CSF; Neupogen



Clinical Trial: Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: University of Maryland Greenebaum Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
Lymphoma
 Drug: carmustine
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: etoposide
 Drug: filgrastim
 Drug: gemcitabine
 Drug: melphalan
 Drug: paclitaxel
 Drug: rituximab
 Drug: sargramostim
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Autologous Stem Cell Transplantation Using High Dose Carmustine and Melphalan Plus Gemcitabine Followed by Rituximab and Consolidation Chemotherapy in Patients with Poor Prognosis, Relapsed, or Refractory Intermediate and High Grade B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: September 1998

OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/ etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a historical control population. II. Evaluate the ability of posttransplant rituximab therapy in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma remaining after high dose therapy in these patients. III. Evaluate quality of life parameters and assess the risk of secondary malignancies following this treatment regimen in these patients.

PROTOCOL OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days. At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week continuing through rituximab therapy. At approximately 3 and 9 months posttransplant, patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide, etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Patients are followed at least every 6 weeks to 3 months until death.

PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

--Prior/Concurrent Therapy--

  • See Disease Characteristics

--Patient Characteristics--

  • Age: 18 to 75
  • Performance status: See Disease Characteristics; ECOG 0-2 (ECOG 3-4 acceptable if based solely on pain)
  • Life expectancy: Not specified
  • Hematopoietic: CD34 cells at least 1,000/g
  • Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal; No active chronic hepatitis or liver cirrhosis
  • Renal: Creatinine no greater than 3.0 mg/dL
  • Cardiovascular: No evidence for clinically significant functional impairment; Left ventricular ejection fraction at least 45%; Patients with lower ejection fractions may be included if a formal cardiological evaluation reveals no evidence for clinically significant functional impairment
  • Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted; If unable to complete pulmonary function tests due to bone pain or fracture, must have a high resolution CT scan of the chest and acceptable blood arterial gases defined as PO2 greater than 70
  • Other: HIV negative; No active infection that is unresponsive to intravenous antibiotics; Not pregnant or nursing; Effective contraception required of all fertile patients

Location Information


Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Study chairs or principal investigators

Aaron P. Rapoport,  Study Chair,  University of Maryland Greenebaum Cancer Center   

More Information

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

Study ID Numbers:  CDR0000066399; MSGCC-9740; NCI-V98-1432
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003397
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 Filgrastim.

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.