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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002348
• Other study ID #: 241A
• Secondary ID: IDD-007
• Status: Completed
• Phase: Phase 2

Study information

• Verified date: March 1996
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Mitoguazone

Locations

Country	Name	City	State
United States	ILEX Oncology Inc	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation