LymphomaPhase 2NCT00002578
Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
A Phase 2 study testing cytarabine, gallium nitrate and leucovorin calcium in people with Lymphoma, run by Roswell Park Cancer Institute at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- cytarabine, gallium nitrate and leucovorin calcium
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 1994to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- cytarabine, gallium nitrate, leucovorin calcium, methotrexate
- Keywords
- 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
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
gallium nitrateDrug
methotrexateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2004 (estimated)
- Study startAug 1994
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lawrence P. Leichman, MD, Study chair, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002578
- Sponsor's protocol ID
- DS 96-26
- Other IDs
- RPCI-DS-96-26, UTHSC-9235011358, NCI-T94-0043D
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 1999
- Last updated
- 6 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002578
- Acronym / sponsor ID
- DS 96-26
- Conditions
- Lymphoma
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1994
- Primary completion
- Jan 2007 (actual)
- First posted
- 20 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytarabine | Drug | – |
| gallium nitrate | Drug | – |
| leucovorin calcium | Drug | – |
| methotrexate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence P. Leichman, MD study chair
Albany Medical College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytarabine, gallium nitrate and leucovorin calcium in people with Lymphoma, run by Roswell Park Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.