Tissue Repair in Stem Cell Transplant Recipients
RhG-CSF (Filgrastim) Treatment of Severe Epithelial/Endothelial or Solid Organ-Specific Tissue Damage In Stem Cell Transplant Recipients
Primary Objective:
1. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation.
Secondary Objective:
1. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available.
Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test.
Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only.
Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment.
This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- U.T.M.D. Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients who underwent allogeneic bone marrow or peripheral blood stem cell transplantation.
- Patients should have engrafted with WBC concentration >3000/ul. Patients should have acute GVHD overall > grade 2 or chronic GVHD.
- Patients with acute GVHD or chronic GVHD including patients refractory to steroid treatment.
- Donors and patients must be of different gender.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
- The only acceptable consent form is the one attached at the end of this protocol.
- Patients agree to biopsy tissue areas unaffected by GVHD for only research purposes.
Exclusion Criteria:
- Patients who are allergic to rhG-CSF.
- Patients who had any prior allogeneic stem cell transplantation using a sex mismatched donor other than the donor used for the previous stem cell allotransplantation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Filgrastim Injections
|
5 mg/kg ID Once Daily x 1 Week
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Donor Derived Cells After G-CSF Therapy
Lasso di tempo: Baseline + 8 Weeks post transplant
|
In each patient, the number of donor derived (dd) cells in solid organ tissue specimens measured by biopsy of relevant tissue at initiation of rhG-CSF treatment (baseline) and at eight weeks post allogeneic transplant.
|
Baseline + 8 Weeks post transplant
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Martin J. Korbling, MD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ID02-300
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Filgrastim
-
Cancer Institute and Hospital, Chinese Academy...Zhejiang Cancer Hospital; Changhai Hospital; Fudan University; Fujian Cancer Hospital e altri collaboratoriCompletato
-
National Cancer Institute (NCI)CompletatoRabdomiosarcoma | Sarcoma sinoviale | Sarcoma di Ewing | MPNST | Sarcoma ad alto rischioStati Uniti
-
Eurofarma Laboratorios S.A.CompletatoNeutropenia nel cancro al senoBrasile
-
PfizerHospira, now a wholly owned subsidiary of PfizerCompletatoCancro al seno non metastaticoUngheria, Spagna
-
Medical University of BialystokSconosciutoAumentare la forza muscolare nei pazienti con distrofia muscolarePolonia
-
Trio FertilityCompletatoInsufficienza ovarica primaria | Insufficienza ovarica prematuraCanada
-
Ottawa Hospital Research InstituteCompletatoCancro al seno in fase inizialeCanada
-
Biologics & Biosimilars Collective Intelligence...Henry Ford Health System; HealthPartners Institute; Amgen; Aetna, Inc.; Harvard Pilgrim... e altri collaboratoriCompletatoCancro al seno | Cancro ai polmoni
-
PfizerCompletato
-
Thomas Jefferson UniversityReclutamentoMieloma multiplo | Linfoma di Hodgkin | Linfoma non HodgkinStati Uniti