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
NCT number | NCT00002348 |
Other study ID # | 241A |
Secondary ID | IDD-007 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated |
Verified date | March 1996 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
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. |
Country | Name | City | State |
---|---|---|---|
United States | ILEX Oncology Inc | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Genzyme, a Sanofi Company |
United States,
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
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