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Home > "G" Clinical Trials Conditions > Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma  Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
For Condition: AIDS-related diffuse small cleaved cell lymphoma,AIDS-related small noncleaved cell lymphoma,AIDS-related lymphoblastic lymphoma,AIDS-related diffuse mixed cell lymphoma,AIDS-related immunoblastic large cell lymphoma,AIDS-related peripheral/systemic lymphoma,AIDS-related diffuse large cell lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
Synopsis: RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients with AIDS -related non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Assess the response rate and duration of response of patients with AIDS-related non-Hodgkin's lymphoma (NHL) treated with gallium nitrate (GAN) after they have failed first-line chemotherapy. II. Define the qualitative and quantitative toxic effects of GAN in patients with AIDS-related NHL. III. Determine the pharmacokinetic parameters of GAN in patients with AIDS-related NHL, and attempt to correlate those parameters with response. PROTOCOL OUTLINE: Single-Agent Chemotherapy. Gallium nitrate, GAN, NSC-15200. PROJECTED ACCRUAL: Up to 35 patients will be accrued. If fewer than 3 or 6 or more responses are seen in the first 20 patients treated, the study will close. Accrual is expected to require 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Pathologically verified, refractory, intermediate- or high-grade non-Hodgkin's lymphoma of any stage; Prior or concurrent leptomeningeal disease associated with systemic lymphoma allowed; Lumbar puncture required at entry unless performed within 30 days prior to entry; Concurrent intrathecal chemotherapy required for such patients; No primary CNS non-Hodgkin's lymphoma - HIV infection documented by ELISA and confirmed by Western blot; No severe, acute opportunistic infection; No acute or intermittent infection (other than oropharyngeal candidiasis) requiring treatment within 2 weeks of entry - Bidimensionally measurable or evaluable disease (i.e., bone marrow involvement only) required - No prior or concomitant second malignancy except: Inactive, nonvisceral Kaposi's sarcoma not requiring chemotherapy; Curatively treated nonmelanomatous skin cancer; Curatively treated in situ cervical carcinoma --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic therapy allowed - Chemotherapy: At least 1 potentially curative chemotherapy regimen for lymphoma required; Hematologic nadir surpassed since chemotherapy (generally 2 weeks regardless of G-CSF use); Waiting period waived at the discretion of the principal investigator if patient well-being would be compromised; No concomitant chemotherapy - Endocrine therapy: No concomitant hormonal therapy - Radiotherapy: Prior radiotherapy allowed; No concomitant radiotherapy - Surgery: Not specified - Other: No concomitant investigational anticancer or anti-infective agents; No concomitant aminoglycosides, amphotericin B, or foscarnet; Concomitant required supportive care allowed, including: Established antiretroviral and antiviral medications; Medications for MAI; Medications for CMV (including for prophylaxis) --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 - Life expectancy: At least 6 weeks - Hematopoietic: (in the absence of marrow infiltration); Absolute granulocyte count at least 750/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 7.5 g/dL - Hepatic: Bilirubin less than 1.25 times normal; AST no greater than 3.0 times normal - Renal: Calculated creatinine clearance greater than 60 mL/min - Cardiovascular: No myocardial infarction within 6 months; No history of congestive heart failure; No angina; No serious arrhythmia requiring treatment - Other: No pregnant women; Effective contraception required of fertile patients - Blood/body fluid analyses to determine eligibility and imaging studies and physical exams for tumor measurement completed within 14 days prior to registration; screening exams (other than blood/body fluid analyses) and imaging studies of nonmeasurable disease or uninvolved organs (including bone marrow aspirate/biopsy) completed within 30 days prior to registration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceLeichman, Study Chair, Roswell Park Cancer Institute
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: CDR0000063666; RPCI-DS-96-26,NCI-T94-0043D,UTHSC-9235011358
Study Start Date: August 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002578
Other Aids-Related Peripheral/systemic Lymphoma Studies:
1. Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
2. Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
3. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
4. Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
5. Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
Related Studies:
Other AIDS-related peripheral/systemic lymphoma Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
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