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A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitoguazone
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Lymphoma, Non-Hodgkin, Acquired Immunodeficiency Syndrome, Lymphoma, AIDS-Related, Mitoguazone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ILEX Oncology Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
December 16, 2020
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00002348
Brief Title
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma
Official Title
Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, HIV Infections
Keywords
Lymphoma, Non-Hodgkin, Acquired Immunodeficiency Syndrome, Lymphoma, AIDS-Related, Mitoguazone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mitoguazone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ILEX Oncology Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782453217
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9060550
Citation
Levine AM, Tulpule A, Tessman D, Kaplan L, Giles F, Luskey BD, Scadden DT, Northfelt DW, Silverberg I, Wernz J, Espina B, Von Hoff D. Mitoguazone therapy in patients with refractory or relapsed AIDS-related lymphoma: results from a multicenter phase II trial. J Clin Oncol. 1997 Mar;15(3):1094-103. doi: 10.1200/JCO.1997.15.3.1094.
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A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma

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