Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00002578
First received: November 1, 1999
Last updated: February 1, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Lymphoma
Drug: cytarabine
Drug: gallium nitrate
Drug: leucovorin calcium
Drug: methotrexate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Estimated Enrollment: 35
Study Start Date: August 1994
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002578

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Lawrence P. Leichman, MD Albany Medical College
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00002578     History of Changes
Other Study ID Numbers: DS 96-26, RPCI-DS-96-26, UTHSC-9235011358, NCI-T94-0043D
Study First Received: November 1, 1999
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Acquired Immunodeficiency Syndrome
HIV Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Methotrexate
Gallium nitrate
Levoleucovorin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014