Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Genzyme
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002348
  Purpose

To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).


Condition Intervention Phase
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Mitoguazone
Phase II

Study Type: Interventional
Study Design: Treatment, Dose Comparison, Safety Study
Official Title: Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.

  Eligibility

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

Inclusion Criteria

Patients must have:

  • HIV positivity by ELISA confirmed by Western blot.
  • AIDS-related NHL that is refractory or relapsed.
  • Life expectancy of at least 12 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Concomitant malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.
  • Active uncontrolled bacterial infection, viral infection (other than herpes simplex), or fungal infection (other than oropharyngeal candidiasis) that requires treatment within 2 weeks of study entry.
  • Significant cardiovascular disease.

Concurrent Medication:

Excluded:

  • Hormonal therapy (except medications given for muscle wasting, such as testosterone or Megace).
  • Other chemotherapy.
  • Investigational anti-cancer drugs.

Concurrent Treatment:

Excluded:

  • Concomitant radiation to sites other than CNS.

Patients with the following prior conditions are excluded:

Prior malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.

Recommended:

  • Prophylaxis for PCP and oral candidiasis.

Required in patients with leptomeningeal disease:

  • Intrathecal methotrexate or cytarabine (Ara-C).
  • Leucovorin.

Required in patients with leptomeningeal disease:

Cranial radiation to a helmet field.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002348

Locations
United States, Texas
ILEX Oncology Inc
San Antonio, Texas, United States, 782453217
Sponsors and Collaborators
Genzyme
  More Information

Publications:
Study ID Numbers: 241A, IDD-007
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002348     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Lymphoma, Non-Hodgkin
Acquired Immunodeficiency Syndrome
Lymphoma, AIDS-Related
Mitoguazone

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Infection
Mitoguazone
Therapeutic Uses
Retroviridae Infections
Lymphoma
RNA Virus Infections
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Lymphatic Diseases
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 27, 2009