Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
Recruitment status was Active, not recruiting
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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 | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Drug: Stanford V regimen Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate |
Phase 2 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients |
Estimated Enrollment: | 30 |
Study Start Date: | May 1997 |
OBJECTIVES:
- 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.
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/mm^3).
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior therapy for Hodgkin's disease
- Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
![](https://webarchive.library.unt.edu/web/20130228113807im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Italy | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 |
Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
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Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00003262 History of Changes |
Other Study ID Numbers: | CDR0000066154, ITA-GICAT-POS5, EU-97022 |
Study First Received: | November 1, 1999 |
Last Updated: | November 2, 2010 |
Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma |
stage IV adult Hodgkin lymphoma AIDS-related peripheral/systemic lymphoma HIV-associated Hodgkin lymphoma |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hodgkin Disease Lymphoma Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Bleomycin Doxorubicin Epirubicin Mechlorethamine Etoposide Prednisone Vinblastine Vincristine Lenograstim Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2013