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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Lymphoma, Non-Hodgkin HIV Infections

Keywords

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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Mitoguazone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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ILEX Oncology Inc

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 9060550 (View on PubMed)

Other Identifiers

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IDD-007

Identifier Type: -

Identifier Source: secondary_id

241A