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

CompletedPhase 2

Sponsor: Genzyme, a Sanofi Company

Conditions: Lymphoma, Non-Hodgkin, HIV Infections

Interventions: Mitoguazone

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

San Antonio, Texas, United States