Completed

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

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What is being tested

Mitoguazone

Drug
Who is being recruted

Blood-Borne Infections+23

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorGenzyme, a Sanofi Company
Last updated: December 19, 2020
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorGenzyme, a Sanofi Company
Last updated: December 19, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsLymphoma, B-CellAcquired Immunodeficiency SyndromeLymphoma, Non-HodgkinHIV InfectionsLymphoma, AIDS-Related

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

ILEX Oncology Inc

San Antonio, United StatesOpen ILEX Oncology Inc in Google Maps
CompletedOne Study Center