- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002578
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Determine the response rate and duration of response in patients with AIDS-related non-Hodgkin's lymphoma treated with gallium nitrate after failure on first-line chemotherapy regimen. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients. III. Determine the pharmacokinetic parameters of this regimen in these patients, and determine if there is a correlation between those parameters and response.
OUTLINE: Patients receive gallium nitrate IV continuously on days 1-7. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Patients who relapse after achieving CR may be retreated in the absence of disease progression. Treatment for relapse after a second CR is at the discretion of the principal investigator. Patients with leptomeningeal disease at study entry must receive intrathecal (IT) methotrexate with IV leucovorin calcium or IT cytarabine. Patients who develop leptomeningeal disease while on study may continue treatment with gallium nitrate but must also receive IT methotrexate and leucovorin calcium (with or without radiotherapy) or IT cytarabine. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033-0800
- USC/Norris Comprehensive Cancer Center
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven stage I-IV AIDS-related non-Hodgkin's lymphoma Intermediate- or high-grade disease HIV infection documented by ELISA and confirmed by Western blot Must have received at least 1 potentially curative chemotherapy regimen for lymphoma Must be past the hematologic nadir resulting from prior chemotherapy (generally 2 weeks from onset of prior therapy regardless of filgrastim (G-CSF) use) Waiting period waived at the discretion of the principal investigator if patient well-being would be compromised At least 1 site of bidimensionally measurable or evaluable disease (e.g., bone marrow involvement only) History of leptomeningeal disease associated with systemic lymphoma allowed No primary CNS non-Hodgkin's lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Granulocyte count at least 750/mm3* Platelet count at least 50,000/mm3* Hemoglobin at least 7.5 g/dL* * Unless bone marrow infiltrated by lymphoma Hepatic: Bilirubin less than 1.25 times upper limit of normal AST no greater than 3.0 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No history of congestive heart failure No angina No serious arrhythmia requiring treatment Other: No other prior or concurrent malignancy except: Inactive, nonvisceral Kaposi's sarcoma not requiring chemotherapy Curatively treated basal cell or squamous cell skin cancer Curatively treated carcinoma in situ of the cervix No severe, acute opportunistic infection No acute or intermittent infection (other than oropharyngeal candidiasis) requiring treatment within 2 weeks before study entry Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior biologic therapy allowed Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: No concurrent investigational anticancer or anti-infective therapy No concurrent aminoglycosides, amphotericin B, or foscarnet Concurrent required supportive care allowed, including: Non-investigational antiretroviral and antiviral medications Medications for Mycobacterium avium DISEASE CHARACTERISTICS: Histologically proven stage I-IV AIDS-related non-Hodgkin's lymphoma Intermediate- or high-grade disease HIV infection documented by ELISA and confirmed by Western blot Must have received at least 1 potentially curative chemotherapy regimen for lymphoma Must be past the hematologic nadir resulting from prior chemotherapy (generally 2 weeks from onset of prior therapy regardless of filgrastim (G-CSF) use) Waiting period waived at the discretion of the principal investigator if patient well-being would be compromised At least 1 site of bidimensionally measurable or evaluable disease (e.g., bone marrow involvement only) History of leptomeningeal disease associated with systemic lymphoma allowed No primary CNS non-Hodgkin's lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Granulocyte count at least 750/mm3* Platelet count at least 50,000/mm3* Hemoglobin at least 7.5 g/dL* * Unless bone marrow infiltrated by lymphoma Hepatic: Bilirubin less than 1.25 times upper limit of normal AST no greater than 3.0 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No history of congestive heart failure No angina No serious arrhythmia requiring treatment Other: No other prior or concurrent malignancy except: Inactive, nonvisceral Kaposi's sarcoma not requiring chemotherapy Curatively treated basal cell or squamous cell skin cancer Curatively treated carcinoma in situ of the cervix No severe, acute opportunistic infection No acute or intermittent infection (other than oropharyngeal candidiasis) requiring treatment within 2 weeks before study entry Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior biologic therapy allowed Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: No concurrent investigational anticancer or anti-infective therapy No concurrent aminoglycosides, amphotericin B, or foscarnet Concurrent required supportive care allowed, including: Non-investigational antiretroviral and antiviral medications Medications for Mycobacterium avium intracellulare infection Medications for cytomegalovirus (CMV) infection or CMV infection prophylaxis infection Medications for cytomegalovirus (CMV) infection or CMV infection prophylaxis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Antidotes
- Vitamin B Complex
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Leucovorin
- Calcium
- Levoleucovorin
- Cytarabine
- Methotrexate
- Gallium nitrate
Other Study ID Numbers
- DS 96-26
- RPCI-DS-96-26
- UTHSC-9235011358
- NCI-T94-0043D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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