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.

Condition	Treatment or Intervention	Phase
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	Drug: gallium nitrate	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

California
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Lawrence P. Leichman,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000063666; RPCI-DS-96-26; NCI-T94-0043D; UTHSC-9235011358
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002578
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08