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

NCT00002348 | Completed Phase 2

• 2 other identifiers: 241AIDD-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma, Non-Hodgkin; HIV Infections

Keywords

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

Interventions

Mitoguazone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (1)

ILEX Oncology Inc

San Antonio, Texas, 782453217, United States

Location

Related 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. doi: 10.1200/JCO.1997.15.3.1094.

  PMID: 9060550 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; HIV Infections; Acquired Immunodeficiency Syndrome; Lymphoma, AIDS-Related

Interventions

Mitoguazone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Slow Virus Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: December 19, 2020

Record last verified: 1996-03

Locations

US (1)