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Home > "A" Clinical Trials Conditions > A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma  A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Completed
Sponsor(s): ILEX Oncology ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
ILEX Oncology Inc
San Antonio, Texas, 782453217
United States
Additional Information:
Study ID Numbers: 241A; IDD-007
Study Start Date:
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002348
Other Lymphoma, Non-Hodgkin Studies:
1. Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors
2. Tumor Lysate Pulsed-Dendritic Cell Vaccines after High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
3. Randomized double cord blood transplant study
4. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
5. Proleukin in Combination with Rituxan in Patients with Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
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A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
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