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

Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002348
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Lymphoma, Non-Hodgkin

Keywords

Lymphoma, Non-Hodgkin, Acquired Immunodeficiency Syndrome, Lymphoma, AIDS-Related, Mitoguazone

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.

Interventions

DRUGMitoguazone

Sponsors

Genzyme, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026