A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin HIV Infections |
Drug: Mitoguazone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002348 History of Changes |
| Other Study ID Numbers: | 241A, IDD-007 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Lymphoma, Non-Hodgkin Acquired Immunodeficiency Syndrome Lymphoma, AIDS-Related Mitoguazone |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lymphoma Lymphoma, Non-Hodgkin Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |
Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Mitoguazone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013