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Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: March 8, 2002   Last Updated: April 18, 2009   History of Changes
Sponsor: Lymphoma Trials Office
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00032149
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Biological: filgrastim
Drug: cyclophosphamide
Drug: etoposide
Drug: mitoxantrone hydrochloride
Drug: prednisolone
Drug: vincristine sulfate
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Effects of treatment on response rate, time to disease progression, and survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
  • Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:

    • Prior diagnosis of acquired immune deficiency syndrome (AIDS)
    • CD4 count < 100,000/mm3
    • ECOG performance status > 2

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032149

Locations
United Kingdom, England
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
King's College Hospital
London, England, United Kingdom, W1T 4TJ
St. Georges, University of London
London, England, United Kingdom, SW17 ORE
United Kingdom, Scotland
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
Lymphoma Trials Office
Investigators
Study Chair: Ruth Pettengell, MD St George's, University of London
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069261, BNLI-GOODRISKHIV, EU-20144
Study First Received: March 8, 2002
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00032149     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Sensory System Agents
Therapeutic Uses
Analgesics
Etoposide
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Bleomycin
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Prednisolone

ClinicalTrials.gov processed this record on November 09, 2009