Alexander Disease |
ALX; AxD; demyelinogenic leukodystrophy; dysmyelinogenic leukodystrophy; fibrinoid degeneration of astrocytes; leukodystrophy with Rosenthal fibers |
Clinical Trial: Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
This study is no longer recruiting patients.
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage II adult Hodgkin's disease AIDS-related peripheral/systemic lymphoma stage III adult Hodgkin's disease stage IV adult Hodgkin's disease HIV-associated Hodgkin's disease stage I adult Hodgkin's disease | Procedure: chemotherapy Procedure: biological response modifier therapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Drug: bleomycin Drug: doxorubicin Drug: epirubicin Drug: etoposide Drug: filgrastim Drug: mechlorethamine Drug: prednisone Drug: vinblastine Drug: vincristine | Phase II |
MedlinePlus related topics: Hodgkin's Disease; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Chemotherapy in Patients with Hodgkin's Disease and HIV Infection: Stanford V Regimen for Low Risk Patients, EBVP Regimen for High Risk Patients
Study start: May 1997
OBJECTIVES: I. Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone.
PROTOCOL OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm3). Low risk patients (those with no risk factors) receive the EBVP regimen, as follows: Epirubicin intravenously on day 1 Bleomycin intramuscularly or intravenously on day 1 Vinblastine intravenously on day 1 Prednisone orally on days 1-5 Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses. High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows: Doxorubicin and vinblastine intravenously on days 1 and 15 Mechlorethamine intravenously on day 1 Vincristine and bleomycin intravenously on days 8 and 22 Etoposide intravenously on days 15 and 16 Prednisone orally daily Patients also receive daily injections of G-CSF on days 3-7, 9-13, 17-21, and 23-26. This schedule is repeated every 28 days for 3 courses. Patients are followed every 2 months the first year and then every 3 months thereafter.
PROJECTED ACCRUAL: 20-30 patients will initially be accrued in this study.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically proven Hodgkin's disease:
- Clinical or pathologic stage II - IV
- Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms Confirmed HIV infection
--Prior/Concurrent Therapy--
- No prior therapy for Hodgkin's disease
- Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
--Patient Characteristics--
Age: 18 and over
Performance status: WHO 0-4
Life expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Not specified
Cardiovascular: No severe cardiac disease
Pulmonary: No severe pulmonary disease
Other:
- No severe neurologic or metabolic disease
- No concurrent or prior second malignancy except: *Nonmelanomatous skin cancer *In situ cancer of the cervix
Location Information
Italy
Centro di Riferimento Oncologico - Aviano, Aviano, 33081, Italy
Umberto Tirelli, Study Chair, Centro di Riferimento Oncologico - Aviano
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003262
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Alexander Disease (National Institute of Neurological Disorders and Stroke)
- Alexander Disease (Cleveland Clinic)

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